Bone anchor assemblies and related instrumentation

ABSTRACT

Bone anchor assemblies and related instrumentation are disclosed herein. In some embodiments, a modular bone anchor assembly allows for a bone anchor to be driven into bone and a head or receiver member to be attached thereto at some later point in time. The bone anchor can have a smaller footprint than the complete assembly, which can improve visualization and anatomical spatial awareness during insertion of the bone anchor and during other surgical steps performed prior to attaching the head or receiver member to the bone anchor. A variety of modular head types are disclosed, as are various instruments for driving a bone anchor, attaching a head to a bone anchor, removing a head from a bone anchor, and making a unilateral attachment to a head of a bone anchor assembly. Drive interfaces for driving a bone anchor are disclosed, as are features that allow a bone anchor to act as a fixation point for soft tissue retraction, disc space distraction, derotation, and the like.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.15/208,847 filed on Jul. 13, 2016, and this application is acontinuation-in-part of U.S. application Ser. No. 15/208,872 filed onJul. 13, 2016, each of which is hereby incorporated herein by reference.

FIELD

Bone anchor assemblies and related instrumentation are disclosed herein.

BACKGROUND

Bone anchor assemblies can be used in orthopedic surgery to fix boneduring healing, fusion, or other processes. In spinal surgery, forexample, bone anchor assemblies can be used to secure a spinal fixationelement to one or more vertebrae to rigidly or dynamically stabilize thespine. Bone anchor assemblies can also be used as an engagement pointfor manipulating bone (e.g., distracting, compressing, or rotating onevertebra with respect to another vertebra, reducing vertebral or longbone fractures, and so forth).

When performing various surgeries, such as spinal decompression,deconstruction, and fusion procedures, spatial anatomical awareness anddirect visualization can be challenging for the surgeon. For example,these procedures can be disruptive to local native anatomy, implant andinstrument geometry and configuration can obscure visualization, andtrends in less-invasive surgery demand smaller working channels. In viewof these and other challenges, there is a continual need for improvedbone anchor assemblies and related instrumentation.

SUMMARY

Bone anchor assemblies and related instrumentation are disclosed herein.In some embodiments, a modular bone anchor assembly allows for a boneanchor to be driven into bone and a head or receiver member to beattached thereto at some later point in time. The bone anchor can have asmaller footprint than the complete assembly, which can improvevisualization and anatomical spatial awareness during insertion of thebone anchor and during other surgical steps performed prior to attachingthe head or receiver member to the bone anchor. A variety of modularhead types are disclosed, as are various instruments for driving a boneanchor, attaching a head to a bone anchor, removing a head from a boneanchor, and making a unilateral attachment to a head of a bone anchorassembly. Drive interfaces for driving a bone anchor are disclosed, asare features that allow a bone anchor to act as a fixation point forsoft tissue retraction, disc space distraction, derotation, and thelike.

In some embodiments, a bone anchor assembly can include a head thatdefines a cavity, the head including proximal and distal ends thatdefine a central proximal-distal axis; a collet disposed in the cavity,the collet comprising a plurality of fingers configured to expandradially-outward to retain the collet within the cavity; and a shankhaving a head portion retained within the collet.

The head can include first and second opposed arms that define arod-receiving recess therebetween. Each arm can include a cross-sectionthat facilitates a dovetail unilateral mating with an attachmentinstrument. Each arm can include a cross section defined by an outersurface, an inner surface, and first and second engagement surfacesextending between the inner and outer surfaces. The first and secondengagement surfaces can extend at an oblique angle with respect to aplane defined by the central proximal-distal axis of the head and acentral axis of the rod-receiving recess. The first and secondengagement surfaces can be angled towards each other as the surfacesapproach the central proximal-distal axis of the head. The cavity caninclude one or more keyways in which the collet is slidably received torestrict rotation of the collet relative to the head while allowinglongitudinal translation of the collet relative to the head. The headcan include opposed first and second arms, each of the arms having areduction tab that extends proximally therefrom. The head can includeopposed first and second arms that define a first rod-receiving recesstherebetween and a lateral wing portion that defines a secondrod-receiving recess therein. The head can include an integral rodportion. The collet can be insertable into a distal end of the head. Thecollet can be longitudinally translatable within the cavity. The colletcan include one or more wings slidably received within keyways formed inthe head. The collet can include first and second opposed arms thatdefine a rod-receiving recess therebetween. Each arm of the collet caninclude a recess formed on an interior surface thereof for engagementwith a removal or assembly instrument. The recess can be open to bothlateral ends of the arm. The recess can include a proximal-facingsurface, a distal-facing surface, a radially-inward facing surface, andan abutment surface that connects the proximal-facing, distal-facing,and inward-facing surfaces such that the recess is open to only onelateral end of the arm. The collet can be retained in the head withoutswaging. The fingers of the collet can be configured to deform from aresting position as the collet is loaded into a distal end of thecavity. The cavity can include: a proximal portion that defines a seatthat faces in a proximal direction; a middle portion that defines aspherical seat that faces in a proximal direction; and a first shelfthat projects radially-inward into the cavity, the first shelf beingdefined at the transition between the proximal and middle portions ofthe cavity. The cavity can include: a distal portion that defines a seatthat faces in a distal direction; and a second shelf that projectsradially-inward into the cavity, the second shelf being defined at thetransition between the middle and distal portions of the cavity. Thefirst shelf can bear against the exterior surfaces of the fingers todeform the fingers radially-inward from the resting position as thecollet is inserted into the cavity. The fingers can be configured toexpand radially-outward within the proximal portion of the cavity toretain the collet in the cavity. The fingers of the collet can beconfigured to deform from a resting position as the head portion of theshank is loaded into a distal end of the collet and, once the headportion is advanced into the collet, the fingers can be configured toreturn towards their resting position to capture the head portion withinthe collet. The shank can be free to pivot relative to the collet whenthe head portion is received within the fingers of the collet before thecollet is locked to the head. Proximal advancement of the head withrespect to the collet can wedge the collet fingers between the headportion of the shank and the interior of the cavity, thereby lockingmovement of the shank with respect to the head. The head portion of theshank can include a drive interface for applying torque to the shank orfor attaching instruments to the shank. The drive interface can includea cavity with an internal thread, the internal thread being interruptedby a plurality of longitudinal channels. A proximal-facing surface ofthe shank can include a plurality of proximally-extending projectionsfor applying countertorque to the shank. Each projection can include aramped surface that extends obliquely from a plane transverse to acentral longitudinal axis of the shank and an abutment surface thatextends parallel to the central longitudinal axis of the shank. Eachprojection can include a first abutment surface that extends parallel toa central longitudinal axis of the shank and a second abutment surfacethat extends parallel to the central longitudinal axis of the shank.

In some embodiments, a method of assembling a bone anchor assemblyincludes inserting a collet into a cavity formed in a head of the boneanchor assembly by: deforming a plurality of fingers of the colletradially-inward to allow the collet to pass through a distal opening ofthe cavity; and expanding the plurality of fingers radially-outward oncethe collet is disposed in the cavity to retain the collet within thecavity; and after inserting the collet into the cavity, inserting a headportion of a bone anchor into the collet by: deforming the fingers ofthe collet radially-outward to allow the head portion of the bone anchorto pass through a distal opening defined by the fingers; and collapsingthe plurality of fingers radially-inward once the head portion isdisposed within the collet to retain the head portion within the collet.

The method can include translating the collet distally within the cavityto wedge the fingers of the collet between the head portion of the boneanchor and an interior surface of the cavity. Translating the colletdistally can include tightening a set screw to the head of the boneanchor assembly to urge a rod disposed in the head into contact with thecollet to move the head proximally. The method can include driving thebone anchor into bone prior to attaching the collet and the head to thebone anchor.

In some embodiments, a head insertion instrument includes a sleevehaving opposed arms movable towards and away from one another toselectively couple the sleeve to a head of a bone anchor assembly; apush rod disposed within the sleeve and configured to translate axiallywith respect to the sleeve, the push rod having a first bearing surface;and a release element disposed within the sleeve and configured totranslate axially with respect to the sleeve, the release elementincluding a second bearing surface and opposed arms aligned with theopposed arms of the sleeve; wherein the instrument prevents separationof a head of a bone anchor assembly from the sleeve when the head is notfully seated on a bone anchor.

When a head coupled to the sleeve is not fully seated on a bone anchor,advancement of the push rod can advance the release element withoutspreading the arms of the release element or the arms of the sleeve,thereby preventing separation of the head from the instrument. When ahead coupled to the sleeve is fully seated on a bone anchor, advancementof the push rod can cause the first bearing surface to cam over thesecond bearing surface to spread the arms of the release element and thearms of the sleeve, thereby separating the head from the instrument. Thearms of the sleeve can include arcuate shelves that extendradially-inward from the arms, the shelves being configured to bereceived within corresponding grooves formed in a head of a bone anchorassembly. The arms of the sleeve can include a shoulder to limit distaltravel of the release element relative to the sleeve. A proximal end ofthe push rod can be coupled to a button or lever that can be depressedto translate the push rod longitudinally with respect to the sleeve. Thepush rod can be biased proximally with respect to the sleeve. The firstand second bearing surfaces can be ramped. The first bearing surface canbe formed on an exterior of the push rod and the second bearing surfacecan be formed on an interior of the arms of the release element. Therelease element can include a distal projection configured to protrudefrom a distal end of the sleeve to contact a bone anchor. The releaseelement can include opposed tabs that slide within correspondingchannels formed in the sleeve to restrict rotation of the releaseelement relative to the sleeve.

In some embodiments, a method of assembling a bone anchor assemblyincludes driving a bone anchor of the bone anchor assembly into a bone;engaging opposed arms of a sleeve of an inserter instrument with a headof the bone anchor assembly to couple the head to the sleeve; with thehead coupled to the sleeve, inserting a proximal end of the bone anchorinto a distal end of the head; and advancing a push rod distally withinthe sleeve, wherein advancing the push rod separates the head from thesleeve only when the head is fully seated on the bone anchor.

When the head is not fully seated on the bone anchor, advancement of thepush rod can advance a release element within the sleeve withoutspreading the arms of the sleeve, thereby preventing separation of thehead from the instrument. When the head is fully seated on the boneanchor, advancement of the push rod can cause a first bearing surface ofthe push rod to cam over a second bearing surface of a release elementdisposed within the sleeve to spread the arms of sleeve, therebyseparating the head from the instrument. The method can include ejectingthe bone anchor from the head when the push rod is advanced distallywhile the head is not fully seated on the bone anchor. The head can beejected by a distal projection of a release element slidably disposed inthe sleeve.

In some embodiments, a driver instrument includes a sleeve having anengagement feature for engaging a corresponding engagement feature of abone anchor, the sleeve including a throughbore in which a ball bearingis disposed; a driver shaft rotatably disposed within the sleeve, adistal end of the driver shaft being configured to engage a bone anchorto drive the bone anchor into bone, the driver shaft having a firstgroove formed therein; a collar defining a cavity in which a proximalportion of the sleeve is received and having a second groove formedtherein; wherein the collar is slidable between a locked position inwhich the driver shaft is maintained at a fixed longitudinal positionwith respect to the sleeve and is free to rotate with respect to thesleeve, and an unlocked position in which the driver shaft is free totranslate longitudinally with respect to the sleeve and is free torotate with respect to the sleeve.

In the locked position the second groove of the collar can be offsetfrom the throughbore of the sleeve such that the collar holds the ballbearing in a position in which the ball bearing is partially disposed inthe first groove formed in the driver shaft. In the unlocked positionthe second groove of the collar can be aligned with the throughbore ofthe sleeve, allowing the ball bearing to move in a radially-outwarddirection, out of engagement with the first groove formed in the drivershaft. The instrument can include a bias element configured to bias thesleeve distally relative to the collar. The engagement feature of thesleeve can include a plurality of ramped projections that extenddistally from the distal-facing surface of the sleeve, each projectionhaving a ramped surface that extends obliquely from a plane transverseto a central longitudinal axis of the sleeve and an abutment surfacethat extends parallel to the central longitudinal axis of the sleeve.

In some embodiments, a driver instrument can include a sleeve having anengagement feature for engaging a corresponding engagement feature of abone anchor; a driver shaft rotatably disposed within the sleeve, adistal end of the driver shaft being configured to engage a bone anchorto drive the bone anchor into bone, the driver shaft having a threadformed on an exterior surface thereof; a collar defining a cavity inwhich a proximal portion of the sleeve is received and having aninterior thread formed therein such that the collar threadably engagesthe driver shaft; wherein the collar is rotatable with respect to thedriver shaft to advance the sleeve longitudinally with respect to thedriver shaft without rotating the sleeve relative to the driver shaft.

The collar can include a hole formed therein that is aligned with agroove formed in the sleeve. The instrument can include a pin insertedthrough the hole and into the groove to maintain the sleeve at a fixedlongitudinal position relative to the collar while allowing the sleeveto rotate relative to the collar. The engagement feature of the sleevecan prevent rotation of the sleeve relative to a bone anchor in bothclockwise and counterclockwise directions. The engagement feature of thesleeve can include a plurality of projections that extend distally fromthe distal-facing surface of the sleeve, each of the projectionsincluding a first abutment surface that extends parallel to a centrallongitudinal axis of the sleeve and a second abutment surface thatextends parallel to the central longitudinal axis of the sleeve. Theengagement feature of the sleeve can include a plurality of angledteeth.

In some embodiments, a unilateral attachment instrument includes a bodythat defines a recess configured to receive an arm of a receiver memberof a bone anchor assembly therein, thereby preventing lateraltranslation and axial rotation of the receiver member relative to thebody, the body defining a central longitudinal axis; and a lock armpivotally coupled to the body and configured to engage an arm of areceiver member of a bone anchor assembly to prevent axial translationof the receiver member relative to the body.

The central longitudinal axis of the body can be offset from a centrallongitudinal axis of a receiver member when an arm of the receivermember is disposed in the recess. The body can include a tube portionhaving a central longitudinal axis that is offset from the centrallongitudinal axis of the body. The central longitudinal axis of the tubeportion can be coaxial with a central longitudinal axis of a receivermember when an arm of the receiver member is disposed in the recess. Aninterior of the tube portion can be threaded. An exterior of the tubeportion can include at least one of a flat and an annular groove. Theinstrument can include a release button configured to pivot the lock armrelative to the body. The recess can be configured to grip multiplesides of an arm of a receiver member. The recess can be configured tomate with a receiver member by a dovetail connection. The recess caninclude a curved face and first and second planar faces that extend fromthe curved face. When coupled to a receiver member having arod-receiving recess, the first and second planar faces can extend at anoblique angle with respect to a plane defined by a central longitudinalaxis of the receiver member and a central axis of the rod-receivingrecess. The first and second planar faces can be angled towards eachother as the faces approach the central longitudinal axis of a receivermember received in the recess. The lock arm can include a ridge thatprojects radially-inward from the arm to engage a corresponding grooveformed in a receiver member received in the recess.

In some embodiments, a bone anchor assembly can include a receivermember having proximal and distal ends that define a centralproximal-distal axis; an insert attached to the receiver member, theinsert and the receiver member defining a cavity; a collet disposed inthe cavity and retained within the cavity by the insert, the colletincluding a plurality of fingers; and a shank that extends through theinsert, the shank having a head portion retained within the fingers ofthe collet.

The insert can include a ridge received within a groove formed in thereceiver member to attach the insert to the receiver member. The insertcan be radially collapsible and expandable to facilitate insertion ofthe insert into the receiver member. The insert can be threaded into anopen distal end of the receiver member. The collet can be insertableinto the distal end of the receiver member without deforming the collet.The receiver member can include first and second opposed arms thatdefine a rod-receiving recess therebetween. The fingers of the colletcan be configured to deform from a resting position as the head portionof the shank is loaded into a distal end of the collet and, once thehead portion is advanced into the collet, the fingers can be configuredto return towards their resting position to capture the head portionwithin the collet. The shank can be free to pivot relative to the colletwhen the head portion is received within the fingers of the colletbefore the collet is locked to the receiver member. Proximal advancementof the receiver member with respect to the collet can wedge the colletfingers between the head portion of the shank and the interior of theinsert, thereby locking movement of the shank with respect to thereceiver member. The collet can include a compression cap and a colletring. The compression cap and the collet ring can be independentlylongitudinally-translatable relative to the receiver member whendisposed within the cavity. The compression cap can be slidably receivedwithin an opening formed in the collet ring. The collet ring can includea proximal opening in which the compression cap is slidably received andthe fingers of the collet can extend distally from the collet ring. Thecompression cap can include one or more flats that interact withrespective one or more flats of the receiver member to limit rotation ofthe compression cap relative to the receiver member about the centralproximal-distal axis. The cavity can include an upper portion having acylindrical inner sidewall that constrains a cylindrical outer sidewallof the collet ring when the collet ring is received therein. Tighteninga closure element to the receiver member can (i) urge a bearing surfaceof the compression cap against a proximal portion of the head of theshank and (ii) urge the collet fingers against a distal portion of thehead of the shank.

In some embodiments, a method of assembling a bone anchor assembly caninclude inserting a collet into a cavity formed in a receiver member ofthe bone anchor assembly by passing the collet through a distal openingof the cavity without deforming the collet; after inserting the colletinto the cavity, attaching an insert to the receiver member of the boneanchor assembly to prevent the collet from moving distally through thedistal opening of the cavity; and after attaching the insert to thereceiver member, inserting a head portion of a bone anchor through acentral opening of the insert and into the collet by: deforming thefingers of the collet radially-outward to allow the head portion of thebone anchor to pass through a distal opening defined by the fingers; andcollapsing the plurality of fingers radially-inward once the headportion is disposed within the collet to retain the head portion withinthe collet.

The method can include translating the receiver member proximallyrelative to the collet to wedge the fingers of the collet between thehead portion of the bone anchor and an interior surface of the insert.Translating the receiver member proximally can include tightening a setscrew to the receiver member to urge a rod disposed in the receivermember into contact with the collet to move the receiver memberproximally. The method can include driving the bone anchor into boneprior to attaching the collet and the receiver member to the boneanchor. The collet can include a compression cap and a collet ring, thefingers extending distally from the collet ring. The method can includeindependently longitudinally translating the compression cap and thecollet ring within the cavity. The method can include sliding thecompression cap axially within an opening formed in the collet ring. Thecompression cap can include one or more flats that interact withrespective one or more flats of the receiver member to limit rotation ofthe compression cap relative to the receiver member about a centralproximal-distal axis of the receiver member. The method can includetightening a closure element to the receiver member to (i) urge abearing surface of the compression cap against a proximal portion of thehead of the bone anchor and (ii) urge the collet fingers against adistal portion of the head of the bone anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a bone anchor assembly and a spinalrod;

FIG. 1B is an exploded perspective view of the bone anchor assembly ofFIG. 1A;

FIG. 1C is another exploded perspective view of the bone anchor assemblyof FIG. 1A;

FIG. 1D is a sectional side view of the bone anchor assembly of FIG. 1Aas the bone anchor is introduced into the collet;

FIG. 1E is a sectional side view of the bone anchor assembly of FIG. 1Awith the bone anchor fully seated within the collet;

FIG. 1F is a sectional side view of the bone anchor assembly of FIG. 1Awith a spinal rod seated therein prior to locking;

FIG. 1G is a sectional side view of the bone anchor assembly of FIG. 1Awith a spinal rod seated and locked therein;

FIG. 1H is a sectional side view of the bone anchor assembly of FIG. 1Awith a spinal rod seated therein and the bone anchor locked in anon-coaxial position with respect to the receiver member;

FIG. 2A is a front view of the receiver member of the bone anchorassembly of FIG. 1A;

FIG. 2B is a side view of the receiver member of FIG. 2A;

FIG. 2C is a top view of the receiver member of FIG. 2A;

FIG. 2D is a bottom view of the receiver member of FIG. 2A;

FIG. 2E is a perspective top view of the receiver member of FIG. 2A;

FIG. 2F is another perspective top view of the receiver member of FIG.2A;

FIG. 2G is a perspective bottom view of the receiver member of FIG. 2A;

FIG. 2H is another perspective bottom view of the receiver member ofFIG. 2A;

FIG. 2I is a sectional top view of the receiver member of FIG. 2A;

FIG. 2J is a sectional front view of the receiver member of FIG. 2A;

FIG. 3A is a front view of the collet of the bone anchor assembly ofFIG. 1A;

FIG. 3B is a side view of the collet of FIG. 3A;

FIG. 3C is a top view of the collet of FIG. 3A;

FIG. 3D is a bottom view of the collet of FIG. 3A;

FIG. 3E is a perspective top view of the collet of FIG. 3A;

FIG. 3F is another perspective top view of the collet of FIG. 3A;

FIG. 3G is a perspective bottom view of the collet of FIG. 3A;

FIG. 3H is another perspective bottom view of the collet of FIG. 3A;

FIG. 3I is a top view of the collet of FIG. 3A shown with an alternativerecess shape;

FIG. 3J is a perspective top view of the collet of FIG. 3I;

FIG. 3K is another perspective top view of the collet of FIG. 3I;

FIG. 4A is a perspective top view of the bone anchor of the bone anchorassembly of FIG. 1A;

FIG. 4B is a perspective bottom view of the bone anchor of FIG. 4A;

FIG. 4C is a top view of the bone anchor of FIG. 4A;

FIG. 4D is a sectional side view of the bone anchor of FIG. 4A;

FIG. 4E is a side view of the bone anchor of FIG. 4A;

FIG. 4F is a perspective top view of the bone anchor of FIG. 4A, shownwith an alternative drive feature;

FIG. 4G is a top view of the bone anchor of FIG. 4F;

FIG. 4H is a perspective top view of the bone anchor of FIG. 4A, shownwith an alternative drive feature;

FIG. 4I is a top view of the bone anchor of FIG. 4H;

FIG. 4J is a perspective top view of the bone anchor of FIG. 4A, shownwith an alternative drive feature;

FIG. 4K is a top view of the bone anchor of FIG. 4J;

FIG. 5A is a perspective view of a reduction head that can be used inthe bone anchor assembly of FIG. 1A;

FIG. 5B is a perspective view of a tandem rod connector head that can beused in the bone anchor assembly of FIG. 1A;

FIG. 5C is a perspective view of the bone anchor assembly of FIG. 1A,shown with a head having a built-in rod;

FIG. 5D is a side view of a rod introducer instrument attached to thebone anchor assembly of FIG. 5C;

FIG. 5E is a sectional side view of the rod introducer instrument andbone anchor assembly of FIG. 5D;

FIG. 5F is a perspective view of a head having a built-in rod that canbe used in the bone anchor assembly of FIG. 1A;

FIG. 5G is an exploded perspective view of the head of FIG. 5F shownwith the collet of the bone anchor assembly of FIG. 1A;

FIG. 5H is a sectional side view of the head and collet of FIG. 5G;

FIG. 5I is a perspective view of a rod introducer instrument attached tothe bone anchor assembly of FIG. 5F;

FIG. 5J is a sectional side view of the rod introducer instrument andbone anchor assembly of FIG. 5I;

FIG. 6A is a perspective view of a step in a method of securing a spinalrod to first and second vertebrae;

FIG. 6B is a perspective view of another step in a method of securing aspinal rod to first and second vertebrae;

FIG. 6C is a perspective view of another step in a method of securing aspinal rod to first and second vertebrae;

FIG. 6D is a perspective view of another step in a method of securing aspinal rod to first and second vertebrae;

FIG. 6E is a perspective view of another step in a method of securing aspinal rod to first and second vertebrae;

FIG. 6F is a perspective view of another step in a method of securing aspinal rod to first and second vertebrae;

FIG. 6G is a perspective view of another step in a method of securing aspinal rod to first and second vertebrae;

FIG. 6H is a perspective view of another step in a method of securing aspinal rod to first and second vertebrae;

FIG. 7A is a perspective view of a driver instrument;

FIG. 7B is an exploded perspective view of the driver instrument of FIG.7A;

FIG. 7C is a sectional side view of the driver instrument of FIG. 7A ina locked configuration;

FIG. 7D is a sectional side view of the driver instrument of FIG. 7A inan unlocked configuration;

FIG. 7E is a perspective view of a step in a method of driving a boneanchor using the driver instrument of FIG. 7A;

FIG. 7F is a perspective view of another step in a method of driving abone anchor using the driver instrument of FIG. 7A;

FIG. 7G is a perspective view of another step in a method of driving abone anchor using the driver instrument of FIG. 7A;

FIG. 8A is a perspective view of a driver instrument;

FIG. 8B is a sectional side view of the driver instrument of FIG. 8A;

FIG. 8C is an exploded perspective view of the driver instrument of FIG.8A;

FIG. 8D is a perspective view of a step in a method of driving a boneanchor using the driver instrument of FIG. 8A;

FIG. 8E is a perspective view of another step in a method of driving abone anchor using the driver instrument of FIG. 8A;

FIG. 8F is a perspective view of another step in a method of driving abone anchor using the driver instrument of FIG. 8A;

FIG. 9 is a perspective view of a driver instrument;

FIG. 10 is a sectional side view of a head removal instrument;

FIG. 11A is a perspective view of a head attachment instrument;

FIG. 11B is an exploded side view of the instrument of FIG. 11A;

FIG. 11C is a perspective view of the outer sleeve of the instrument ofFIG. 11A;

FIG. 11D is a perspective view of the push rod and release element ofthe instrument of FIG. 11A;

FIG. 11E is a sectional side view of the instrument of FIG. 11Aattaching a head to a bone anchor;

FIG. 11F is a sectional side view of the instrument of FIG. 11Areleasing from a head after the head is attached to a bone anchor;

FIG. 11G is a sectional side view of the instrument of FIG. 11Aattempting to attach a head to a bone anchor;

FIG. 11H is a sectional side view of the instrument of FIG. 11Apreventing release of a head due to insufficient attachment of the headto a bone anchor;

FIG. 12A is a front view of a unilateral attachment instrument;

FIG. 12B is a side view of the instrument of FIG. 12A;

FIG. 12C is a sectional view of the instrument of FIG. 12A;

FIG. 12D is a perspective view of the instrument of FIG. 12A;

FIG. 12E is a sectional top view of the instrument of FIG. 12A coupledto a receiver member;

FIG. 12F is a sectional side view of the instrument of FIG. 12A coupledto a receiver member;

FIG. 12G is a perspective view of attaching a head to a bone anchorusing the instrument of FIG. 12A;

FIG. 12H is a perspective view of introducing a rod using the instrumentof FIG. 12A;

FIG. 12I is a perspective view of inserting a set screw using theinstrument of FIG. 12A;

FIG. 12J is a perspective view of reducing a rod and inserting a setscrew using the instrument of FIG. 12A;

FIG. 12K is a perspective view of tightening a set screw and applyingcountertorque using the instrument of FIG. 12A;

FIG. 13A is an exploded perspective view of a receiver member, collet,and insert of a bone anchor assembly;

FIG. 13B is a sectional exploded perspective view of the bone anchorassembly of FIG. 13A;

FIG. 13C is a sectional perspective view of the bone anchor assembly ofFIG. 13A;

FIG. 13D is a sectional side view of the bone anchor assembly of FIG.13A;

FIG. 13E is a sectional side view of the bone anchor assembly of FIG.13A with a shank of the bone anchor inserted into the receiver member;

FIG. 13F is a sectional perspective view of the bone anchor assembly ofFIG. 13A with a rod secured to the bone anchor assembly by a set screw;

FIG. 13G is a sectional exploded perspective view of the bone anchorassembly of FIG. 13A, shown with a threaded insert;

FIG. 13H is a sectional perspective view of the bone anchor assembly ofFIG. 13G;

FIG. 13I is a sectional side view of the bone anchor assembly of FIG.13G with a shank of the bone anchor assembly inserted into the receivermember;

FIG. 13J is a sectional perspective view of the bone anchor assembly ofFIG. 13G with a rod secured to the bone anchor assembly by a set screw;

FIG. 13K is a perspective view from below of the bone anchor assembly ofFIG. 13G;

FIG. 14A is a perspective view of a bone anchor assembly and a spinalrod;

FIG. 14B is an exploded perspective view of the bone anchor assembly andspinal rod of FIG. 14A;

FIG. 14C is a sectional side view of the bone anchor assembly and spinalrod of FIG. 14A;

FIG. 14D is a perspective view of a receiver member of the bone anchorassembly of FIG. 14A;

FIG. 14E is a perspective view of a compression cap of the bone anchorassembly of FIG. 14A;

FIG. 14F is a perspective view of a collet ring of the bone anchorassembly of FIG. 14A;

FIG. 14G is a perspective view of a retaining ring of the bone anchorassembly of FIG. 14A;

FIG. 14H is a sectional side view of the bone anchor assembly of FIG.14A in a first configuration;

FIG. 14I is a sectional side view of the bone anchor assembly of FIG.14A in a second configuration;

FIG. 14J is a sectional side view of the bone anchor assembly of FIG.14A in a third configuration; and

FIG. 14K is a sectional side view of the bone anchor assembly of FIG.14A in a fourth configuration.

DETAILED DESCRIPTION

Bone anchor assemblies and related instrumentation are disclosed herein.In some embodiments, a modular bone anchor assembly allows for a boneanchor to be driven into bone and a head or receiver member to beattached thereto at some later point in time. The bone anchor can have asmaller footprint than the complete assembly, which can improvevisualization and anatomical spatial awareness during insertion of thebone anchor and during other surgical steps performed prior to attachingthe head or receiver member to the bone anchor. A variety of modularhead types are disclosed, as are various instruments for driving a boneanchor, attaching a head to a bone anchor, removing a head from a boneanchor, and making a unilateral attachment to a head of a bone anchorassembly. Drive interfaces for driving a bone anchor are disclosed, asare features that allow a bone anchor to act as a fixation point forsoft tissue retraction, disc space distraction, derotation, and thelike.

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments.

Bone Anchor Assemblies

FIGS. 1A-1H illustrate an exemplary embodiment of a bone anchor assembly100. As shown, the assembly 100 can include a head or receiver member200, a collet 300, a shank or bone anchor 400, and a closure mechanismor set screw 102. The bone anchor assembly 100 can be modular such thatany of a variety of heads 200 can be coupled to any of a variety of boneanchors 400, and such that the assembly 100 can be fit together in situ.The bone anchor 400 can be bottom loaded into the receiver member 200and can be captured by the collet 300 to retain the bone anchor withinthe receiver member while still allowing relative motion therebetween.The set screw 102 can be tightened to wedge the collet 300 between thehead of the bone anchor 400 and the receiver member 200, thereby lockingthe relative position of the bone anchor and the receiver member. Theset screw 102 can also be effective to lock a spinal rod R1 or otherimplant to the bone anchor assembly 100.

In use, the bone anchor 400 can be driven into bone without the head 200being attached thereto. This can result in a lower profile initialconstruct and allow the bone anchor 400 to be placed before other stepsof the procedure are performed, such as exposing the neural elements,removing the facets and disc for fusion, and so forth. As a result,anatomical reference points can be preserved and can be used whentargeting bone anchor 400 insertion. Also, the lower profile can providemore access to the surgical site for the user. The bone anchor 400 canalso be used as a platform for other manipulations, such as distraction,compression, derotation, soft tissue retraction, and the like. Theassembly 100 can also be implanted in the patient in a pre-assembledstate.

FIGS. 2A-2J illustrate the head or receiver member 200 in detail. Thereceiver member 200 can include proximal and distal ends 200 p, 200 dthat define a central proximal-distal axis A1. The proximal end 200 p ofthe receiver member 200 can include a pair of spaced apart arms 202, 204that define a rod-receiving recess 206 therebetween. The rod-receivingrecess 206 can have a central axis A2. The rod-receiving recess 206 canbe open in a proximal direction, such that a rod R1 can be inserted intothe recess by moving the rod distally with respect to the receivermember 200. The inner surfaces of each of the arms 202, 204 can beconfigured to mate with the set screw 102. For example, the innersurfaces of the arms 202, 204 can include threads that correspond toexternal threads formed on the set screw 102. Accordingly, rotation ofthe set screw 102 with respect to the receiver member 200 about the axisA1 can be effective to translate the set screw with respect to thereceiver member axially along the axis A1. Each of the arms 202, 204 canextend from a base portion 208 of the receiver member 200 to a free end.

The arms 202, 204 can include features, such as recesses, dimples,notches, projections, or the like, to facilitate coupling of thereceiver member 200 to various instruments.

For example, the outer surface of each arm 202, 204 can include a grooveor channel 210 formed therein to define a “top notch” feature. In theillustrated embodiment, each arm 202, 204 includes an arcuate groove 210formed in the exterior surface of the arm adjacent the free end of thearm. As described further below, the groove 210 can be engaged with acorresponding projection of an instrument to facilitate coupling of theinstrument to the receiver member 200.

By way of further example, the receiver member 200 can include aunilateral instrument attachment feature. In other words, the receivermember 200 can include a feature that allows rigid attachment of aninstrument thereto by engaging only one arm 202, 204 of the receivermember. An exemplary unilateral attachment feature is shown, in which atleast a portion of each arm 202, 204 has a cross-section thatfacilitates a dovetail unilateral mating with an attachment instrument,e.g., an instrument of the type described below with respect to FIGS.12A-12F. Proximal portions 202 p, 204 p of the arms 202, 204 can benarrowed at a stepped-in ledge 212. As shown in FIG. 2I, the proximalportion 202 p, 204 p of each arm 202, 204 can have a cross-sectiondefined by a generally curved outer surface 214, a generally curvedinner surface 216, and first and second planar dovetail engagementsurfaces 218 extending between the inner and outer surfaces. The firstand second engagement surfaces 218 can extend at an oblique angle withrespect to a plane defined by the central proximal-distal axis A1 of thereceiver member and the central axis A2 of the rod-receiving recess 206.The first and second engagement surfaces 218 of each arm can be angledtowards each other as the surfaces approach the central proximal-distalaxis A1 of the receiver member 200. As described further below, thegeometry of the cross-section of each arm 202, 204 can allow the arm tobe received within a recess of a unilateral attachment instrument torestrict movement of the arm and the receiver member 200 relative to theinstrument.

As another example, the arms 202, 204 can each include a blind hole,through hole, recess, or opening 220 formed in an exterior sidewallthereof. The blind hole 220 can be engaged with a correspondingprojection of an instrument, such as a rocker fork reduction instrument,to facilitate coupling of the instrument to the receiver member 200.

The base portion 208 of the receiver member 200 can define an interiorcavity 222 in which the collet 300 and the head of the bone anchor 400can be received. While any of a variety of cavity shapes can be used,the illustrated cavity 222 includes an upper, proximal portion 224, amiddle portion 226, and a lower, distal portion 228, as shown in FIG.2J.

The upper portion 224 of the cavity 222 can be frustoconical orsubstantially frustoconical about the axis A1, with a spherical orsubstantially spherical seat 230 that faces in a proximal direction. Afirst shelf 232 that projects radially-inward into the cavity 222 can bedefined at the transition between the upper and middle portions 224, 226of the cavity. The middle portion 226 of the cavity 222 can define aspherical or substantially spherical seat 234 that faces in a proximaldirection. In some embodiments, the seat 234 can be conical and/ortapered. The radius of the spherical seat 234 of the middle portion 226of the cavity 222 can be less than the radius of the spherical seat 230of the upper portion 224 of the cavity. A second shelf 236 that projectsradially-inward into the cavity 222 can be defined at the transitionbetween the middle and lower portions 226, 228 of the cavity. The lowerportion 228 of the cavity 222 can define a conical or spherical seat 238that faces in a distal direction.

In some embodiments, the cavity 222 can be entirely defined by interiorsurfaces of a unitary or monolithic receiver member 200. In someembodiments, for example as described below with respect to FIGS.13A-13F and FIGS. 13G-13K, at least a portion of the cavity can bedefined by a retaining ring or insert that is separate from the receivermember.

The receiver member 200 can include features for restricting orpreventing motion of the collet 300 with respect to the receiver member.For example, the receiver member 200 can include features for limitingproximal-distal travel of the collet 300, or for limiting or preventingrotation of the collet. In the illustrated embodiment, the receivermember 200 includes diametrically-opposed keyways 240 sized to receivewings of the collet 300 therein. The keyways 240 can be formed in thecavity 222 and can extend into the arms 202, 204. The wings of thecollet 300 can be slidably received in the keyways 240 to allow thecollet to translate along the axis A1 with respect to the receivermember 200 while restricting or preventing rotation of the collet aboutthe axis A1 with respect to the receiver member. Proximal travel of thecollet 300 within the receiver member 200 can be limited by engagementbetween a proximal-facing surface of the collet wings and adistal-facing shoulder 242 formed at the roof of the keyways 240. Whilemultiple keyways 240 are shown, the receiver member 200 can include onlya single keyway in some embodiments or can include more than twokeyways.

FIGS. 3A-3K illustrate the collet 300 in detail. The collet 300 can bepositioned within the cavity 222 formed in the receiver member 200. Thecollet 300 can be sized such that it is longitudinally translatablewithin the cavity 222, along the axis A1. The collet 300 can begenerally cylindrical with first and second arms 302, 304 extending in aproximal direction to respective free ends of the arms. The first andsecond arms 302, 304 can be aligned with the first and second arms 202,204 of the receiver member 200 such that a recess 306 definedtherebetween is aligned with the rod-receiving recess 206. Accordingly,the rod R1 can be simultaneously cradled between the arms 302, 304 ofthe collet 300 and the arms 202, 204 of the receiver member 200 when therod is disposed in the rod-receiving recess 206.

The collet 300 can include a mating feature configured to limit orprevent certain movement of the collet with respect to the receivermember 200. For example, the collet 300 can include opposed wings orprojections 308 that extend radially-outward from an exterior surface ofthe collet. The wings 308 can be received within the keyways 240described above to allow the collet 300 to translate within the receivermember 200 but to limit proximal travel of the collet and limit orprevent rotation of the collet relative to the receiver member. It willbe appreciated that the keyways 240 can alternatively be formed in thecollet 300 and the projections 308 formed in the cavity 222 of thereceiver member 200. While multiple wings 308 are shown, the collet 300can include only a single wing in some embodiments or can include morethan two wings.

The collet 300 can define a central opening 310 that extends completelythrough the collet along the axis A1. The opening 310 can be sized toreceive a guide wire or needle therethrough, or to receive a drivertherethrough for engaging the drive interface of the bone anchor 400.

The collet 300 can include features for engaging the collet with aninstrument to manipulate the collet, e.g., during insertion or removalof the collet from the receiver member 200. For example, the arms 302,304 of the collet 300 can each include a respective recess 312. Therecess 312 can be engaged with an instrument for removing the collet 300and receiver member 200 from a bone anchor 400, or for assembling thecollet to the receiver member, as explained below with respect to FIG.10. The recess 312 can be open to both lateral ends of the arms 302,304, as shown in FIGS. 3A-3H, or can be open to only one lateral end ofthe arms, as shown in FIGS. 3I-3K. In the latter configuration, therecess 312 can include a proximal-facing surface, a distal-facingsurface, a radially-inward facing surface, and an abutment surface 314that connects the proximal-facing, distal-facing, and inward-facingsurfaces. The abutment surface 314 can be configured to abut with abearing surface of an instrument, as described below.

The collet 300 can include one or more slits formed therein to define aplurality of distally-extending fingers 316. The fingers 316 can beconfigured to deform radially-inward and/or radially-outward from aresting position. The fingers 316 can have resilient properties suchthat, when deformed from their resting position, the fingers are biasedtowards the resting position.

While the illustrated collet 300 includes six fingers 316, it will beappreciated that the collet can include any number of fingers, e.g.,zero, one, two, three, four, five, six, seven, eight, or more. Includinga larger number of fingers 316 can result in each individual fingerbeing narrower in width for a given size collet 300, making the fingereasier to deflect during assembly.

The slits can have an expanded or T-shaped proximal end to provide arelief and allow the fingers 316 to deform to a greater degree with lesseffort or without breaking. The fingers 316 can include areduced-thickness region 318 adjacent their proximal end to encouragebending of the fingers at a predetermined bend zone. The distal-mostends of the fingers 316 can include a curved, tapered, angled, or rampedsurface 320 to provide a lead in for entry of the head of the boneanchor 400 and for wedging the collet fingers between the head of thebone anchor and the receiver member 200. The lead-in surface 320 canface substantially radially-inward. The inner surfaces of the fingers316 can be spherical or substantially spherical. The outer surfaces ofthe fingers 316 can likewise be spherical or substantially spherical. Insome embodiments, the inner surfaces of the fingers 316 each formsections of a common sphere.

In use, the fingers 316 can be deformed from their resting position asthe collet 300 is loaded into the distal end of the cavity 222. Inparticular, the second shelf 236 of the cavity 222 can bear against theexterior surfaces of the fingers 316 to deform the fingersradially-inward from their resting position. Once the collet 300 isadvanced far enough in the proximal direction, the fingers 316 can passthe second shelf 236 and expand radially-outward within the upperproximal portion 224 and/or middle portion 226 of the cavity 222. Theexpanded fingers 316 can have a diameter greater than that of theopening defined by the second shelf 236, such that the collet 300 isretained in the cavity 222. It will be appreciated that the ability todeform and expand the collet 300 within the receiver member 200 canallow the collet to be retained within the cavity 222 withoutnecessarily requiring swaging. Swaging is a common manufacturing processthat involves permanent material deformation to retain one componentwithin another. Deformation of material during the swaging process isless predictable than traditional machining processes and can requirespecial manufacturing controls, which can increase manufacturing cost.The illustrated bone anchor assembly 100 can thus be easier and lessexpensive to manufacture than bone anchor assemblies that requireswaging. While swaging is not necessarily required, in some embodiments,swaging can be used to retain the collet 300 within the cavity 222 or toaugment the retention of the collet.

The fingers 316 can also be deformed from their resting position as thehead of the shank 400 is loaded into the distal end of the collet 300.The receiver member 200 and the collet 300 can be assembled to the headof the shank 400 by applying a distal axial force to the receiver memberover the head of the shank. The head of the shank 400 can bear againstthe distal lead-in surfaces 320 of the fingers 316 to deform the fingersradially-outward from their resting position. Once the head of the shank400 is advanced far enough into the collet 300, the fingers 316 canreturn towards their resting position, capturing the head of the shanktherein to retain the shank within the collet and, by extension, withinthe receiver member 200. When captured within the collet 300, and beforethe collet is locked down within the receiver member 200, the shank 400can still be free to pivot with respect to the collet and to rotateabout the axis A1 relative to the collet. The collet 300 can apply adrag force to the head of the bone anchor 400, e.g., due to a lightinterference fit between the collet fingers 316 and the head of the boneanchor. The drag force can maintain the relative position between thereceiver member 200 and the bone anchor 400 prior to locking theconstruct, e.g., during provisional positioning of the assembly 100, toprevent the receiver member from “flopping” over. The drag force canthus prevent unintended movement prior to locking the assembly 100,while still allowing free movement when intended by the user.

Once assembled to the head of the shank 400, rod insertion and set screw102 locking can be effective to drive the collet 300 distally withrespect to the receiver member 200, wedging the collet fingers 316between the head of the shank and the interior of the middle portion 226of the cavity 222, thereby locking movement of the shank with respect tothe receiver member.

In some embodiments, the collet 300 can include a compression capcomponent and a collet ring component, for example as described belowwith respect to FIGS. 14A-14K.

The set screw 102 can include an exterior thread configured to mate withthe interior threads formed on the arms 202, 204 of the receiver member200. The threaded engagement can allow the set screw 102 to be advancedor retracted along the axis A1 with respect to the receiver member 200by rotating the set screw about the axis A1. The set screw 102 caninclude a driving interface configured to receive a driver for applyinga rotational force to the set screw about the axis A1. The distalsurface of the set screw 102 can be configured to contact and bearagainst a rod R1 disposed in the rod-receiving recess 206 to lock therod to the assembly 100. When tightened against the rod R1, the setscrew 102 can prevent the rod from translating relative to the receivermember 200 along the axis A2 and/or from rotating with respect to thereceiver member about the axis A2. While a set screw 102 is shown, itwill be appreciated that other locking elements can be used instead oraddition, such as a closure cap that advances and locks by quarter-turnrotation, a closure cap that slides in laterally without rotating, a nutthat threads onto an exterior of the receiver member 200, and so forth.In some embodiments, a dual set screw can be used. The dual set screwcan include an outer set screw that bears against the arms 302, 304 ofthe collet 300 to lock the polyaxial movement of the shank 400 relativeto the receiver member 200. The dual set screw can also include an innerset screw threadably mounted in an opening formed in the outer setscrew. The inner set screw can be tightened to bear against the rod R1and to lock the rod to the receiver member 200.

FIGS. 4A-4K illustrate the shank or bone anchor 400 in detail. The boneanchor 400 can include a proximal head portion 402 and a distal shaftportion 404 and can define a central longitudinal bone anchor axis A3.

The distal shaft 404 of the bone anchor 400 can be configured to engagebone and, in the illustrated embodiment, includes an external boneengaging thread 406. The thread form for the distal shaft 404, includingthe number of threads, the pitch, the major and minor diameters, and thethread shape, can be selected to facilitate connection with bone. Theillustrated thread form 406 is a cortical fix thread that transitionsfrom a double lead thread to a quadruple lead thread. Such a thread formcan advantageously increase displacement in the pedicle canal. Otherexemplary thread forms are disclosed in U.S. Patent ApplicationPublication No. 2011/0288599, filed on May 18, 2011, and in U.S. PatentApplication Publication No. 2013/0053901, filed on Aug. 22, 2012, bothof which are hereby incorporated by reference herein. The distal shaft404 can also include other structures for engaging bone, including ahook. The distal shaft 404 can be cannulated, having a central passageor cannula 408 extending the length of the bone anchor 400 to facilitatedelivery of the bone anchor over a guidewire in, for example,minimally-invasive procedures. Other components of the bone anchorassembly 100, including, for example, the set screw 102, the collet 300,and the receiver member 200 can be cannulated or otherwise have anopening to permit delivery over a guidewire. The distal shaft 404 canalso include one or more sidewall openings or fenestrations (not shown)that communicate with the cannula 408 to permit bone in-growth or topermit the dispensing of bone cement or other materials through the boneanchor 400. The sidewall openings can extend radially from the cannula408 through the sidewall of the distal shaft 404. Exemplary systems fordelivering bone cement to the bone anchor assembly 100 and alternativebone anchor configurations for facilitating cement delivery aredescribed in U.S. Patent Application Publication No. 2010/0114174, filedon Oct. 29, 2009, which is hereby incorporated by reference herein. Thedistal shaft 404 of the bone anchor 400 can be coated with materials topermit bone growth, such as, for example, hydroxyapatite, and the boneanchor assembly 100 can be coated partially or entirely withanti-infective materials, such as, for example, tryclosan.

The proximal head portion 402 of the bone anchor 400 can be generally inthe shape of a truncated sphere having a planar proximal surface and anapproximately spherically-shaped distal surface. The illustrated boneanchor assembly 100 is a polyaxial bone screw designed for posteriorimplantation in the pedicle or lateral mass of a vertebra, anterolateralfixation, and/or other indications. The proximal head 402 of the boneanchor 400 can engage the interior of the collet fingers 316 in a balland socket like arrangement in which the proximal head 402 and thedistal shaft 404 can pivot relative to the collet 300 and the receivermember 200.

The head portion 402 of the bone anchor 400 can include a driveinterface for applying torque to the bone anchor, e.g., to drive thebone anchor into bone or to withdraw or retract the bone anchor frombone. The drive interface can also be used to attach various instrumentsto the bone anchor 400, e.g., to allow the bone anchor to serve as aplatform for distraction, compression, derotation, soft tissueretraction, and the like.

As shown in FIGS. 4A-4E, the drive interface can include a proximalcavity 410 and a distal cavity 412. The proximal cavity 410 can besubstantially cylindrical with an internal thread formed therein forengaging a corresponding threaded portion of an instrument. The distalcavity 412 can be shaped to non-rotatably engage the bone anchor 400with a drive tip of a driver instrument. While a hexalobe star driveinterface is shown for the distal cavity 412, it will be appreciatedthat other interfaces can be used instead or in addition, includingslotted, Phillips, square socket, hex socket, pentalobe, and the like.The threaded proximal cavity 410 can allow for rigid instrumentconnection to the bone anchor 400. For example, a threaded outercountertorque tube can be rigidly connected to the threaded interface410, and a driver shaft can be inserted therethrough to apply torque tothe bone anchor 400 via the distal cavity 412. As another example, thethreaded section 410 can allow for connection to the driver shaftitself, e.g., in the case of a driver shaft having a drive interface inthe form of a threaded distal end. The threaded section 410 can alsoallow for rigid connection to an extension tube or shaft for performingdistraction, compression, derotation, retraction, or othermanipulations. The illustrated drive interface can allow a threadedcylindrical driver tool or a standard hexalobe driver tool to be usedinterchangeably. The ability to use different driver instruments withthe same bone anchor 400 can be desirable as it can allow the boneanchor to be driven with a standard driver instrument if a specializeddriver instrument is not available (e.g., as may be the case in arevision surgery in which the original, specialized driver instrument isnot available).

FIGS. 4F-4G illustrate an alternative drive interface. As shown, thedrive interface can include a substantially cylindrical cavity 414 withan internal thread formed therein for engaging a corresponding threadedportion of a driver instrument. The thread can be interrupted by aseries of longitudinal channels 416, such that the channels and theinner-most surface of the thread define a hexalobe drive interface. Thiscan allow a threaded cylindrical driver tool or a standard hexalobedriver tool to be used interchangeably. Because the threaded andhexalobe drive features overlap one another, the height profile of thebone anchor 400 can be reduced, and/or the engaged height of the driverinstrument can be increased. The proximal-facing surface of the head 402of the bone anchor 400 can include countertorque features. As describedfurther below with respect to FIGS. 7A-7G, these features can allow thebone anchor 400 to be engaged with a countertorque sleeve. Theillustrated features include a plurality of ramped projections 420 thatextend proximally from the proximal-facing surface of the head. Eachprojection 420 can include a ramped surface 422 that extends obliquelyfrom a plane transverse to the axis A3 and an abutment surface 424 thatextends parallel to the axis A3. The abutment surfaces 424 can provideunidirectional countertorque engagement.

FIGS. 4H-4I illustrate an alternative drive interface. As shown, thedrive interface can include a substantially cylindrical cavity 414 withan internal thread formed therein for engaging a corresponding threadedportion of a driver instrument. The thread can be interrupted by aseries of longitudinal channels 416, such that the channels and theinner-most surface of the thread define a hexalobe drive interface. Thiscan allow a threaded cylindrical driver tool or a standard hexalobedriver tool to be used interchangeably. Because the threaded andhexalobe drive features overlap one another, the height profile of thebone anchor 400 can be reduced, and/or the engaged height of the driverinstrument can be increased. The proximal-facing surface of the head 402of the bone anchor 400 can include countertorque features. As describedfurther below with respect to FIGS. 8A-8F, these features can allow thebone anchor 400 to be engaged with a countertorque sleeve. Theillustrated features form a “castle” pattern defined by a plurality ofprojections 420 that extend proximally from the proximal-facing surfaceof the head 402. Each projection 420 can include a first abutmentsurface 426 that extends parallel to the axis A3 and a second abutmentsurface 428 that extends parallel to the axis A3. The abutment surfaces426, 428 can provide bidirectional countertorque engagement.

The drive interfaces of FIGS. 4F-4G and FIGS. 4H-4I can include afully-threaded interior. In other words, the threaded portion of thedrive interface can extend substantially the entire depth of the driverecess. This can allow for deeper thread engagement, providing astronger connection between the bone anchor 400 and a driver or otherinstrument. The threaded driver attachment can also allow for the drivershaft to be made stronger as compared to a driver shaft inserted througha threaded outer tube, since the driver shaft can just be a largediameter threaded shaft that is completely solid or solid except for asmall-diameter guidewire cannulation. By increasing the strength of thedriver shaft, the same instrument can be used for other tasks likecompression, distraction, etc. While a hexalobe feature is shown cutinto the threaded interface, it will be appreciated that this can beomitted and the interface can include a continuous, uninterruptedthread, or other types of features can be cut into the threadedinterface.

FIGS. 4J-4K illustrate an alternative drive interface. As shown, thethreaded engagement can be omitted and the drive interface can be asimple hexalobe recess 414 or other standard drive type.

Referring again to FIGS. 1D-1H, an exemplary method of using the boneanchor assembly 100 is described below. The bone anchor assembly 100 canbe provided for a surgery in a state of partial disassembly. Forexample, the bone anchor 400 can be initially separated from thereceiver member 200 and the collet 300. The receiver member 200 and thecollet 300 can be preassembled or can be assembled by the user duringthe surgery.

The bone anchor 400 can be delivered to a target bone site within thepatient and driven to a desired depth along a desired trajectory usingknown techniques. The bone anchor 400 can be driven into the bone beforeor after attaching the receiver member 200 and the collet 300 to thebone anchor. When the bone anchor 400 is driven into the bone beforeattaching the collet 300 and the receiver member 200, the initialconstruct can have a lower profile that can allow the bone anchor to beplaced before other steps of the procedure are performed, such asexposing the neural elements, removing the facets and disc for fusion,and so forth. As a result, anatomical reference points can be preservedand can be used when targeting bone anchor insertion. Also, the lowerprofile can provide more access to the surgical site for the user. Thebone anchor 400 can be driven using driver instruments of the typedescribed herein, including the instrument 700 of FIGS. 7A-7G and theinstrument 800 of FIGS. 8A-8F.

Once driven into the bone, the bone anchor 400 (with or without thereceiver member 200 being attached thereto) can be used as a platformfor other manipulations, such as distraction, compression, derotation,soft tissue retraction, and the like. These tasks can be achieved usinginstruments of the type described herein, including the instrument 700of FIGS. 7A-7G and the instrument 800 of FIGS. 8A-8F.

The receiver member 200 and the collet 200 can be coupled to the head402 of the bone anchor 400. For example, the bone anchor 400 can bebottom-loaded into the receiver member 200 by positioning the receivermember over the head 402 as shown in FIG. 1D and applying adistally-directed axial force to the receiver member. As shown in FIG.1E, the fingers 316 of the collet 300 can be deformed from their restingposition as the head 402 of the shank 400 is loaded into the distal endof the collet and can then return towards their resting position,capturing the head of the shank therein. In this position, the fingers316 of the collet 300 are disposed in the upper proximal portion 224 ofthe cavity 222 in the receiver member 200. Accordingly, the shank 400 isfree to rotate relative to the collet 300 about the axis A1 and to pivotpolyaxially with respect to the collet within a cone of angulationextending out from the axis A1. While the shank 400 is free to moverelative to the collet 300, the collet fingers 316 can apply a dragforce to the shank, as described above. The receiver member 200 can beattached to the bone anchor 400 using a head insertion instrument 1100of the type described below with respect to FIGS. 11A-11H.

Once the receiver member 200 is coupled to the bone anchor 400, thereceiver member can serve as a platform for other steps in a surgicalprocedure, such as distraction, compression, derotation, soft tissueretraction, and the like. For example, a unilateral attachmentinstrument 1200 of the type described below with respect to FIGS.12A-12F can be attached to the receiver member 200 and used to performvarious manipulations, as described below with respect to FIGS. 12G-12K.A user may wish to remove the receiver member 200 and the collet 300from the bone anchor 400, in which case the user can use a head removalinstrument, e.g., of the type describe below with respect to FIG. 10.

The assembled bone anchor assembly 100 can be used to secure an implantto the bone. For example, as shown in FIG. 1F, a spinal rod R1 can beinserted into the rod-receiving recess 206 of the receiver member 200.Before the rod R1 is fully seated and locked within the receiver member200 the bone anchor 400 can remain movable relative to the receivermember. For example, the collet fingers 316 can remain in the upperproximal portion 224 of the cavity 222 such that they are not wedgedbetween the head 402 and the interior surface 234 of the cavity. Asshown in FIG. 1G, the set screw 102 or other closure mechanism can beapplied to the receiver member 200 to drive the rod R1 and/or the collet300 distally within the receiver member. As the collet fingers 316 moveinto the smaller diameter middle portion 226 of the cavity 222, thefingers can be wedged between the exterior surface of the head 402 ofthe shank 400 and the interior surface 234 of the cavity. Wedging thefingers 316 in this manner can be effective to lock movement of the boneanchor 400 relative to the receiver member 200. The bone anchor 400 canbe locked at any of a variety of angles with respect to the receivermember 200, as shown for example in FIG. 1H. Applying the set screw orother closure mechanism 102 can also be effective to lock the rod R1 tolock movement of the rod relative to the receiver member 200. As notedabove, a dual set screw or other construct can be used to independentlylock movement of the shank 400 relative to the receiver member 200 andmovement of the rod R1 relative to the receiver member.

The set screw 102 can be loosened if a user wishes to restore freedom ofmovement of the rod R1 and/or the shank 400 relative to the receivermember 200. In some embodiments, the bone anchor assembly 100 can beconfigured to remobilize automatically when the set screw 102 isloosened. This can advantageously eliminate the need to applysignificant forces to the construct to break the bone anchor 400 freefrom the locked position. Automatic remobilization can be facilitated bythe sphere-in-sphere arrangement provided by the spherical shank head402 and the spherical middle portion 226 of the cavity 222 between whichthe spherical distal portion of the collet fingers 316 are wedged.

Modular Heads

As noted above, the bone anchor assembly 100 can be modular in the sensethat various types or sizes of heads 200 can be coupled to various typesor sizes of shanks 400. In the description above, reference is made to ahead 200 in the form of a receiver member that defines a recess 206 forreceiving a spinal rod. It will be appreciated, however, that variousother head types can be used instead or in addition.

For example, as shown in FIG. 5A, a reduction head 200A can be used. Thereduction head 200A can be substantially similar to the receiver head200 described above, but can include reduction tabs 244 that extendproximally from the arms 202, 204. The reduction tabs 244 can be formedintegrally with the arms 202, 204 and can be configured to be brokenaway after use. In other embodiments, the reduction tabs 244 can beseparate components that are selectively coupled to the arms 202, 204.The reduction tabs 244 can have a cross-sectional shape that matchesthat of the arms 202, 204. The reduction tabs 244 can include a threadedinterior surface such that the tabs serve as a functional extension ofthe arms 202, 204 for set screw insertion or rod reduction.

By way of further example, as shown in FIG. 5B, a tandem rod connectorhead 200B can be used. The tandem rod head 200B can be substantiallysimilar to the receiver head 200 described above, but can include alateral wing portion 246 for attaching the head to a second spinal rod.The wing portion 246 can include first and second opposed arms 248, 250that define a second rod-receiving recess 252 therebetween. A second setscrew (not shown) can be threaded between the opposed arms 248, 250 tolock the second rod in the second rod-receiving recess 252. The rodrecesses 206, 252 can have central axes that are parallel to one anotheras shown, or the central axes can extend at a non-zero angle relative toone another.

As another example, a head having a built-in rod can be used. FIGS.5C-5E illustrate a head 200C that includes a built-in rod. Except asindicated below and as will be readily appreciated by one havingordinary skill in the art, the head 200C can be substantially similar tothe receiver head 200 described above. Instead of first and secondopposed arms 202, 204, the head 200C can include an enclosed proximalportion 254. The set screw 102 can be elongated in the proximal-distaldirection such that the distal surface of the set screw can beardirectly against the collet 300, without an intervening rod. The head200C can include a rod portion 256. The rod portion 256 can extendradially-outward along an axis A4 from an exterior sidewall of the head.The rod portion 256 can be formed integrally with the head 200C or canbe selectively attached thereto. The head 200C can also include a secondrod portion 258 with an engagement feature 260 formed thereon for matingwith various instruments, such as a rod introducer 500. The second rodportion 258 can extend along the axis A4 from an opposite sidewall ofthe head 200C than the sidewall from which the first rod portion 256extends. The engagement feature 260 can be formed at a terminal end ofthe second rod portion 258. The engagement feature 260 can be asubstantially rectangular projection with a dimple formed in aproximal-facing surface thereof. As shown in FIG. 5E, a rod introducerinstrument 500 can be coupled to the engagement feature 260 to allowinsertion of the rod head 200C. In the illustrated embodiment, the rodintroducer 500 includes a recess 502 at a distal end thereof sized toreceive the rectangular portion of the engagement feature 260 thereinsuch that the rod 258 cannot rotate relative to the instrument about theaxis A4. The instrument 500 can include a pusher 504 that translateslongitudinally within a lumen of the instrument to selectively hold anengagement pin 506 in contact with the dimple. When the pusher 504 isadvanced distally within the lumen, it can force the pin 506 intocontact with the dimple to hold the rod 258 firmly to the instrument 500and prevent the rod from translating along the axis A4 with respect tothe instrument. When the pusher 504 is retracted proximally within thelumen, it can allow the pin 506 to move out of engagement with thedimple, thereby allowing the rod 258 to be separated from the instrument500 along the axis A4.

Instead of a second rod portion 258 with an engagement feature 260thereon, or in addition, the enclosed proximal portion 254 of the head200C can include an engagement feature. For example, as shown in FIGS.5F-5J, the head 200C can include first and second cantileveredprojections that define opposed arcuate grooves 264 in the exteriorsurface of the head. The grooves 264 can thus form a top-notch featureas described above. As shown in FIGS. 5I-5J, the grooves 264 can allow aretractor or extension shaft instrument 508 to be coupled to the head200C. The instrument 508 can include first and second arms 510, 512configured to pivot in and out to selectively engage the top-notchfeature 264. The instrument 508 can define a central passage to allowother instruments to be passed therethrough, e.g., a driver instrumentfor advancing the shank portion 400 of the bone anchor assembly 100 or adriver instrument for advancing a set screw 102 within the head portion200C.

FIGS. 6A-6H illustrate an exemplary method of using a head with abuilt-in rod to secure the rod to first and second vertebrae. As shownin FIG. 6A, first and second bone anchors 400_1, 400_2 of the typedescribed above can be driven into respective first and second vertebraeV1, V2. The vertebrae V1, V2 can be adjacent as shown, or can beseparated by one or more intervening vertebrae. The bone anchors 400_1,400_2 can be driven into any part of the vertebrae V1, V2, such as thepedicles, laminae, or lateral masses thereof.

Before attaching receiver members or other heads to the bone anchors400_1, 400_2, or at any other desired time, various other surgical stepscan be performed. For example, decompression work or interbody work,including removal of all or a portion of a spinal disc and insertion ofa fusion cage, can be performed.

As shown in FIG. 6B, a receiver member 200_1 and collet 300_1 of thetype described above can be attached to the first bone anchor 400_1 toform a first bone anchor assembly 100_1. An integrated rod head 200_2and collet 300_2 of the type described above can be attached to thesecond bone anchor 400_2, as shown in FIG. 6C. The method shown can beperformed in a minimally-invasive manner, e.g., one in which discretepercutaneous incisions are formed over each bone anchor 400_1, 400_2 andthe skin surface between the bone anchors is not incised. In this case,the integrated rod head 200_2 can be inserted through the percutaneousopening formed over the second bone anchor 400_2, with the rod portion256 being inserted first. The rod portion 256 can then be tunneled belowthe skin surface into the rod-receiving recess 206 of the receivermember 200_1 of the first bone anchor assembly 100_1. The head 200_2 andcollet 300_2 can then be lowered through the percutaneous opening andattached to the second bone anchor 400_2, as shown in FIG. 6D, to form asecond bone anchor assembly 100_2. Insertion and manipulation of theintegrated rod head 200_2 can be performed with a rod introducerinstrument 508 coupled to the engagement feature of the head (e.g., atopnotch feature as shown or a second rod portion as described abovewith respect to FIGS. 5C-5E).

As shown in FIG. 6E, a set screw 102_1 can be lowered through thepercutaneous incision formed above the first bone anchor assembly 100_1and tightened to secure the rod portion 256 to the first bone anchorassembly. Similarly, as shown in FIG. 6F, a set screw 102_2 can belowered through the second percutaneous incision and tightened to lockthe head 200_2 to the second bone anchor 400_2. The second set screw102_2 can be inserted through the rod introducer instrument 508 asshown. The rod introducer instrument 508 can be used to apply acountertorque force during final tightening of the set screw 102_2. Therod introducer instrument 508 can then be removed, leaving an assembledconstruct attached to both vertebrae V1, V2 as shown in FIGS. 6G-6H. Itwill be appreciated that various manipulations can be performed beforefinal tightening of the set screws 102_1, 102_2, such as compression,distraction, or derotation maneuvers. The rod introducer instrument 508can be used to facilitate these manipulations by acting as a pointthrough which forces can be applied to the bone anchor assembly and thevertebra in which it is implanted.

A number of other modular heads can also be used, including closedpolyaxial modular heads, monoaxial modular heads, biased orfavored-angle (e.g., sagittal or transverse) modular heads, extendedtube or extended tab modular heads, uniplanar (e.g., sagittal ortransverse) modular heads, and so forth. The bone anchor assembly 100can be provided as part of a kit with a plurality of different headtypes or head sizes and a plurality of different shank types or shanksizes to enable the user to select the optimal combination for aparticular use. Dimensions or parameters which can vary among componentsof the kit can include shank length, shank diameter, shank thread type,head size, rod-recess diameter, and the like.

Driver Instruments

FIGS. 7A-7G illustrate an exemplary driver instrument 700 that can beused to drive bone anchors into bone, e.g., bone anchors of the typeshown in FIGS. 4F-4G. As shown, the instrument 700 can include a drivershaft 702, a countertorque sleeve 704, and a collar 706 for coupling thedriver shaft to the countertorque sleeve. The collar 706 can retain oneor more ball bearings 708 therein.

The driver shaft 702 can include proximal and distal ends 702 p, 702 dthat define a longitudinal axis A5. The driver shaft 702 can besubstantially cylindrical, or can have any of a variety of other shapes.The driver shaft 702 can have a hollow central channel or cannulation tofacilitate insertion and use of the driver shaft over a guidewire. Thedistal end 702 d of the driver shaft 702 can include an engagementfeature for engaging a counterpart drive interface of a bone anchor 400.For example, the distal end 702 d of the driver shaft 702 can include anexterior thread configured to mate with an interior thread of the boneanchor 400. The proximal end 702 p of the driver shaft 702 can includeflats or other features for applying a rotational force to the drivershaft. For example, the driver shaft 702 can include flats fornon-rotatably coupling the driver shaft to a powered driver (e.g., anelectric, pneumatic, or hydraulic drill or driver tool) or to a handlefor manually rotating the driver shaft. By way of further example, thedriver shaft 702 can have a handle integrally formed therewith. Thedriver shaft 702 can include a channel or groove 710 formed in anexterior surface thereof for receiving the ball bearings 708.

The countertorque sleeve 704 can include proximal and distal ends 704 p,704 d that define a longitudinal axis A6. The countertorque sleeve 704can define a hollow interior channel in which the driver shaft 702 canbe disposed. The longitudinal axis A6 of the countertorque sleeve 704can be coaxial with the longitudinal axis A5 of the driver shaft 702when the instrument 700 is assembled. The distal end 704 d of thecountertorque sleeve 704 can include an engagement feature for engagingthe countertorque features of the bone anchor 400. The illustratedfeatures include a plurality of ramped projections 712 that extenddistally from the distal-facing surface of the countertorque sleeve 704.Each projection 712 can include a ramped surface that extends obliquelyfrom a plane transverse to the axis A6 and an abutment surface 714 thatextends parallel to the axis A6. The abutment surfaces 714 can bearagainst the abutment surfaces 424 of the bone anchor 400 to preventrotation of the countertorque sleeve 704 relative to the bone anchor inone direction (e.g., in a clockwise direction from the perspective ofthe surgeon as shown). The proximal end 704 p of the countertorquesleeve 704 can include one or more lateral through-bores 716 in whichrespective ones of the ball bearings 708 are received.

The collar 706 can define an interior cavity sized to receive at least aproximal portion of the countertorque sleeve 704. An annular groove orchannel 718 can be formed in the interior cavity of the collar 706 toreceive at least a portion of the ball bearings 708 therein. A biaselement 720 can be positioned within the cavity to bias thecountertorque sleeve 704 distally with respect to the collar 706. Whilea coil spring 720 coaxial with the driver shaft 702 is shown, it will beappreciated that other bias elements can be used instead or in addition,such as leaf springs, torsion springs, and the like. A pin 722 can bepositioned in an elongated slot 724 formed in the collar 706 and a hole726 formed in the countertorque sleeve 704 to hold the collar, spring720, and sleeve together in an assembled state. The elongated slot 724can allow the collar 706 to translate longitudinally along the sleeve704 within a limited range of movement.

The collar 706 can be slidable along the exterior of the countertorquesleeve 704 between a locked configuration and an unlocked configuration.In the locked configuration, as shown in FIG. 7C, the ball bearings 708are disposed partially in the throughbores 716 of the countertorquesleeve 704 and partially in the groove 710 of the driver shaft 702. Thecollar 706 is urged proximally under the bias force of the spring 720,such that the inner groove 718 of the collar is offset from thethroughbores 716 of the countertorque sleeve 704. Accordingly, the innersidewall of the collar 706 holds the ball bearings 708 firmly in contactwith the groove 710 in the driver shaft 702. In the lockedconfiguration, the driver shaft 702 can be maintained at a fixedlongitudinal position with respect to the countertorque sleeve 704 butcan be free to rotate with respect to the countertorque sleeve.

In the unlocked configuration, as shown in FIG. 7D, a distally-directedforce can be applied to the collar 706 to urge the collar distally withrespect to the countertorque sleeve 704. The collar 706 can be pusheddistally to align the inner groove 718 of the collar with thethroughbores 716 of the countertorque sleeve 704, allowing the ballbearings 708 to move in a radially-outward direction, out of engagementwith the groove 710 formed in the driver shaft 702. In the unlockedconfiguration, the driver shaft 702 can be free to translatelongitudinally with respect to the countertorque sleeve 704 and can befree to rotate with respect to the countertorque sleeve.

In use, the driver shaft 702 can be inserted into a bone anchor 400 androtated with respect to the bone anchor to engage the threaded distalend 702 d of the driver shaft with the threaded drive interface of thebone anchor, as shown in FIG. 7E. Before or after coupling the drivershaft 702 to the bone anchor 400, the driver shaft and the bone anchorcan be loaded over a guidewire. The sleeve 704 and collar 706 assemblycan be installed over the driver shaft 702, advancing the sleevedistally until the countertorque features of the sleeve engage thecountertorque features of the bone anchor 400, as shown in FIG. 7F. Inthis position, the ball bearings 708 can engage the groove 710 formed inthe driver shaft 702 to hold the sleeve 704 at a fixed longitudinalposition with respect to the driver shaft and thereby hold the sleeve inengagement with the countertorque features of the bone anchor 400. Arotational force can be applied to the driver shaft 702 (or to thesleeve 704) to drive the bone anchor 400 into bone. When removal of thedriver shaft 702 from the bone anchor 400 is desired, the countertorquesleeve 704 can be held stationary while the driver shaft is rotated inan opposite direction to unthread the driver shaft from the driveinterface of the bone anchor. In some cases, the user may wish to leavethe driver shaft 702 engaged with the bone anchor 400. As shown in FIG.7G, the sleeve 704 and the collar 706 can be removed from the drivershaft 702 (e.g., by advancing the collar distally to release the ballbearings 708 from the driver shaft as described above). The driver shaft702 can be left behind as a post to facilitate other steps in a surgicalprocedure. For example, the driver shaft 702 can serve as an attachmentpoint for a distractor or access port, or can be used to apply aderotation, distraction, or compression force to a vertebra in which thebone anchor 400 is implanted. While not shown in FIGS. 7A-7G, the driverinstrument 700 can include a depth stop, e.g., of the type describedbelow with respect to the driver instrument 800 of FIGS. 8A-8F.

FIGS. 8A-8F illustrate an exemplary driver instrument 800 that can beused to drive bone anchors into bone, e.g., bone anchors of the typeshown in FIGS. 4H-4I. As shown, the instrument 800 can include a drivershaft 802, a countertorque sleeve 804, and a collar 806 for coupling thedriver shaft to the countertorque sleeve. The instrument 800 can includea depth stop 828 to prevent over-insertion of the bone anchor 400.

The driver shaft 802 can include proximal and distal ends 802 p, 802 dthat define a longitudinal axis A7. The driver shaft 802 can besubstantially cylindrical, or can have any of a variety of other shapes.The driver shaft 802 can have a hollow central channel or cannulation tofacilitate insertion and use of the driver shaft over a guidewire. Thedistal end 802 d of the driver shaft 802 can include an engagementfeature for engaging a counterpart drive interface of a bone anchor 400.For example, the distal end 802 d of the driver shaft 802 can include anexterior thread configured to mate with an interior thread of the boneanchor 400. The proximal end 802 p of the driver shaft 802 can includeflats or other features for applying a rotational force to the drivershaft. For example, the driver shaft 802 can include flats fornon-rotatably coupling the driver shaft to a powered driver (e.g., anelectric, pneumatic, or hydraulic drill or driver tool) or to a handlefor manually rotating the driver shaft. By way of further example, thedriver shaft 802 can have a handle integrally formed therewith. Thedriver shaft 802 can include an exterior thread 810 formed adjacent theproximal end of the driver shaft for engaging the collar 806.

The countertorque sleeve 804 can include proximal and distal ends 804 p,804 d that define a longitudinal axis A8. The countertorque sleeve 804can define a hollow interior channel in which the driver shaft 802 canbe disposed. The longitudinal axis A8 of the countertorque sleeve 804can be coaxial with the longitudinal axis A7 of the driver shaft 802when the instrument 800 is assembled. The distal end 804 d of thecountertorque sleeve 804 can include an engagement feature for engagingthe countertorque features of the bone anchor 400. The illustratedfeatures form a “castle” pattern defined by a plurality of projections812 that extend distally from the distal-facing surface of the sleeve804. Each projection 812 can include a first abutment surface 814 thatextends parallel to the axis A8 and a second abutment surface 830 thatextends parallel to the axis A8. The abutment surfaces 814, 830 can bearagainst the abutment surfaces 426, 428 of the bone anchor 400 to preventrotation of the countertorque sleeve 804 relative to the bone anchor inboth clockwise and counterclockwise directions. In some embodiments, theengagement feature can include angled teeth, e.g., in the form of astar-lock or star-grind interface.

The collar 806 can define an interior cavity sized to receive at least aproximal portion of the countertorque sleeve 804. At least a portion ofthe cavity can define an interior thread 832 configured to threadablyengage the exterior thread 810 formed on the driver shaft 802.Accordingly, rotation of the collar 806 about the driver shaft 802 canbe effective to translate the collar longitudinally with respect to thedriver shaft. The collar 806 can include holes or channels 834 formedtherein configured to align with a groove 836 formed in the proximal endof the sleeve 804 when the instrument 800 is assembled. A pin 838 can beinserted through the holes 834 to position the pin within the groove 836formed in the sleeve 804. Accordingly, the sleeve 804 can be maintainedat a fixed longitudinal position relative to the collar 806 while stillbeing free to rotate relative to the collar about the axis A8.

In use, the driver shaft 802 can be inserted into a bone anchor 400 androtated with respect to the bone anchor to engage the threaded distalend 802 d of the driver shaft with the threaded drive interface of thebone anchor, as shown in FIG. 8D. Before or after coupling the drivershaft 802 to the bone anchor 400, the driver shaft and the bone anchorcan be loaded over a guidewire. The sleeve 804 and the collar 806assembly can be installed over the driver shaft 802. The collar 806 canbe rotated to advance the sleeve 804 distally, without rotating thesleeve, until the countertorque features of the sleeve engage thecountertorque features of the bone anchor 400, as shown in FIG. 8E. Inthis position, the sleeve 804 can be sandwiched between a shouldersurface 840 formed in the collar 806 (see FIG. 8B) and theproximal-facing surface of the bone anchor 400, thereby holding thesleeve in engagement with the countertorque features of the bone anchor.A rotational force can be applied to the driver shaft 802 (or to thesleeve 804) to drive the bone anchor 400 into bone. When removal of thedriver shaft 802 from the bone anchor 400 is desired, the countertorquesleeve 804 can be held stationary while the driver shaft is rotated inan opposite direction to unthread the driver shaft from the driveinterface of the bone anchor. In some cases, the user may wish to leavethe driver shaft 802 engaged with the bone anchor 400. As shown in FIG.8F, the sleeve 804 and the collar 806 can be removed from the drivershaft 802, e.g., by rotating the collar to unthread it from the drivershaft. The driver shaft 802 can be left behind as a post to facilitateother steps in a surgical procedure. For example, the driver shaft 802can serve as an attachment point for a distractor or access port, or canbe used to apply a derotation, distraction, or compression force to avertebra in which the bone anchor 400 is implanted.

The depth stop 828 can include a cylindrical sleeve mated to or formedintegrally with the distal end of the countertorque sleeve 804. Thedepth stop 828 can define a hollow interior sized to receive the head402 of the bone anchor 400 therein. As the bone anchor 400 is driveninto the bone, the depth stop 828 will eventually contact the bonesurface and prevent further insertion of the bone anchor. This can helpensure that a sufficient length of the bone anchor 400 is leftprotruding above the bone surface to allow attachment of the receivermember or head 200.

FIG. 9 illustrates another exemplary driver instrument 900 that can beused instead of or in addition to the instruments 700, 800 describedabove. The instrument 900 can include a standard hexalobe driveinterface 902 as shown, or any of a variety of other drive interfaces.

Head Removal Instruments

FIG. 10 illustrates an exemplary instrument 1000 for removing a head 200from a bone anchor 400. As shown, the instrument 1000 can include aninner rod 1002 and an outer sleeve 1004. The outer sleeve 1004 candefine a central lumen or channel sized to receive the inner rod 1002therein. The longitudinal position of the inner rod 1002 with respect tothe outer sleeve 1004 can be adjustable. For example, the inner rod 1002can include an exterior thread that engages a corresponding interiorthread of the outer sleeve 1004 such that rotation of the outer sleeveabout the inner rod is effective to translate the inner rod proximallyor distally relative to the outer sleeve. The distal end of the outersleeve 1004 can define a bearing surface 1006 configured to bear againsta head 200. In the illustrated embodiment, the distal-facing surface1006 of the outer sleeve 1004 is configured to abut and bear against aproximal-facing surface of the head 200. The distal end of the inner rod1002 can include features for engaging the collet 300 to fix alongitudinal position of the collet with respect to the inner rod. Forexample, as shown, the inner rod 1002 can include opposed ears 1008 thatextend radially-outward therefrom. The ears 1008 can be sized to bereceived within the recesses 312 formed in the arms 302, 304 of thecollet 300.

In use, the inner rod 1002 can be advanced distally with respect to theouter sleeve 1004 such that the inner rod protrudes from the outersleeve. The distal end of the inner rod 1002 can be inserted into anassembled bone anchor assembly 100 by positioning the distal end betweenthe arms 302, 304 of the collet 300. The user can then grasp a proximalend of the inner rod 1002 and rotate it 90 degrees about its axisrelative to the collet 300 to position the ears 1008 of the inner rodwithin the recesses 312 of the collet, thereby fixing the longitudinalposition of the collet with respect to the inner rod. The user can thenrotate the outer sleeve 1004 about the inner rod 1002 to advance theouter sleeve distally relative to the inner rod until the outer sleeveabuts the proximal end of the receiver member 200. Continued rotation ofthe outer sleeve 1004 will pull the inner rod 1002, and the collet 300fixed thereto, proximally relative to the receiver member 200 until thecollet fingers 316 are positioned within the upper portion 224 of thecavity 222 formed in the receiver member. When the fingers 316 arepositioned in the upper portion 224 of the cavity 222, they can be freeto deflect radially-outward to release the head 402 of the bone anchor400. Accordingly, once the collet 300 is pulled proximally within thereceiver member 200, the user can apply a proximal pulling force to theinstrument 1000 to separate the receiver member and the collet from thebone anchor 400. The instrument 1000 can include a plunger (not shown)slidably and/or threadably disposed in the inner rod 1002 that can bearagainst and urge the head 402 of the bone anchor 400 distally out of thereceiver member 200, such that proximal pulling forces applied by theuser are not applied (or are not applied to the same degree) to the boneanchor. This can advantageously prevent stressing the bone anchor/boneinterface. After separating the bone anchor 400, the above steps can beperformed in reverse order and in reverse direction to release thereceiver member 200 and the collet 300 from the instrument 1000.

The instrument 1000 can also be used to assemble the collet 300 to thereceiver member 200. For example, the inner rod 1002 can be mated to thecollet 300 and the outer sleeve 1004 can be rotated about the inner rodto pull the inner rod, and the collet coupled thereto, proximally intothe distal end of the receiver element 200. Once the collet fingers 316flex outward to retain the collet 300 within the cavity 222 of thereceiver member 200, the inner rod 1002 can be decoupled from the colletand the instrument 1000 can be separated from the now-assembled receivermember and collet.

Head Insertion Instruments

FIGS. 11A-11H illustrate an exemplary instrument 1100 for attaching thereceiver member 200 to the bone anchor 400. The instrument 1100 can beused for in-situ attachment of the receiver member 200 to the boneanchor 400. In other words, the bone anchor 400 can be implanted in abone and, thereafter, a receiver member 200 can be coupled thereto usingthe instrument 1100.

In a modular bone anchor assembly, it is conceivable that sub-optimalhead attachment can occur, for example if soft tissue or other debrisblocks complete attachment to the bone anchor, or if the user fails toapply sufficient force when mating the head to the bone anchor.Accordingly, it may be desirable to give the user some positiveindication that the head is securely coupled to the bone anchor, or toprevent the head from being released from an insertion instrument if thehead is not securely attached to the bone anchor. This functionality cangive the user increased confidence that an adequate connection has beenmade between the receiver member and the bone anchor.

The instrument 1100 can be configured such that the receiver member 200is only released from the instrument when the receiver member issecurely coupled to the bone anchor 400. This can give the userconfidence that the receiver member 200 is securely attached, since theuser will only be able to remove the inserter instrument 1100 when asecure attachment is achieved.

As shown, the instrument 1100 can include a push rod 1102, an outersleeve 1104, and a release element 1106. The outer sleeve 1104 caninclude proximal and distal ends 1104 p, 1104 d that define alongitudinal proximal-distal axis A9. The outer sleeve 1104 can define acentral lumen or channel sized to receive the push rod 1102 and therelease element 1106 therein. The proximal end 1104 p of the outersleeve 1104 can include a handle 1108 or other feature to facilitategripping of the instrument 1100 by the user. The distal end 1104 d ofthe sleeve 1104 can include opposed slits such that the distal end isseparated into first and second cantilevered arms 1110. The arms 1110can be at least somewhat flexible such that the free ends of the armsare movable towards and away from one another to selectively engage areceiver member 200. The slits can include enlarged proximal cut-outs toprovide a stress relief and facilitate such movement of the arms 1110.The free ends of the arms 1110 can include an engagement feature forengaging a corresponding feature of the receiver member 200. In theillustrated embodiment, the arms 1110 include arcuate shelves 1112 thatextend radially-inward from the arms, the shelves being configured toseat within corresponding arcuate grooves 210 of the receiver member 200to secure the receiver member to the outer sleeve 1104. The arms 1110can have at least a first position in which the shelves 1112 are seatedwithin the grooves 210 of the receiver member 200 to secure the receivermember to the instrument 1100, and a second position in which the armsare deflected radially-outward from the first position to unseat theshelves from the grooves of the receiver member to release the receivermember from the instrument.

The arms 1110 can also include a shoulder 1114 that engages acorresponding shoulder of the release element 1106 to limit distaltravel of the release element relative to the outer sleeve 1104. Inother words, the shoulders 1114 of the arms 1110 can prevent the releaseelement 1106 from falling out of the distal end of the outer sleeve1104.

The push rod 1102 can be slidably disposed within the outer sleeve 1104such that the push rod can translate longitudinally relative to theouter sleeve. A proximal end of the push rod 1102 can be coupled to abutton, lever, or other actuator 1116, which can be actuated by a userto advance the push rod distally within the outer sleeve 1104. A biaselement 1118 can be disposed between the push rod 1102 and the outersleeve 1104 to bias the push rod proximally with respect to the outersleeve. Accordingly, upon release of the button 1116, the push rod 1102can be retracted proximally within the sleeve 1104 under the bias of thebiasing element 1118. While a coil spring is shown, it will beappreciated that other biasing elements can be used instead or inaddition. The distal end of the push rod 1102 can include a bearingsurface 1120 configured to bear against a corresponding interior bearingsurface of the release element 1106, as described further below. Thebearing surface 1120 of the push rod 1102 can be conical, curved,tapered, or ramped.

The release element 1106 can include a distal projection 1122 configuredto protrude from the distal end 1104 d of the outer sleeve 1104 tocontact a bone anchor 400. The release element 1106 can include opposedarms 1124 that extend proximally from the release element. The arms 1124can be configured to flex toward and/or away from each other duringoperation of the instrument 1100. The arms 1124 can include recessesformed therein that define a bearing surface 1126 configured to bearagainst the bearing surface 1120 of the push rod 1102. The bearingsurfaces 1126 of the arms 1124 can be conical, curved, tapered, orramped. The release element 1106 can include features to limit movementof the release element with respect to the outer sleeve 1104. Forexample, the release element 1106 can include a distal-facing shoulder1128 configured to engage the proximal-facing shoulder 1114 of the outersleeve 1104 to limit distal longitudinal travel of the release elementrelative to the sleeve. By way of further example, the release element1106 can include opposed tabs 1130 that project radially-outwardtherefrom and slide within the slits formed in the outer sleeve 1104 torestrict rotation of the release element with respect to the outersleeve. The tabs 1130 can ensure that the arms 1124 of the releaseelement 1106 are aligned with the arms 1110 of the outer sleeve 1104.

Operation of the instrument 1100 is illustrated in FIGS. 11E-11H. Asshown, a receiver member 200 or other modular head component can beloaded into the instrument 1100 by engaging the shelves 1112 of theouter sleeve 1104 with grooves 210 formed in the receiver member,thereby securing the receiver member to the outer sleeve. The instrument1100 can then be used to attach the receiver member 200 to a bone anchor400. The bone anchor 400 can have been previously implanted in bone. Asthe instrument 1100 is used to lower the receiver member 200 down overthe bone anchor 400, the distal projection 1122 of the release element1106 comes into contact with the bone anchor. Continued advancement ofthe instrument 1100 with respect to the bone anchor 400 can cause therelease element 1106 to slide proximally within the outer sleeve 1104.

As shown in FIGS. 11E-11F, when the head 402 of the bone anchor 400 isfully-seated within the receiver member 200, the user can depress theactuation button 1116 to release the receiver member from the insertioninstrument 1100. Specifically, pressing the button 1116 can cause thepush rod 1102 to translate distally within the outer sleeve 1104. As thepush rod 1102 urges the release element 1106 distally, distaladvancement of the release element is prevented by the bone anchor 400.Accordingly, the bearing surface 1120 of the push rod 1102 bears againstthe bearing surface 1126 of the release element 1106 to splay the arms1124 of the release element radially-outward. As the arms 1124 of therelease element 1106 move radially-outward, they push the arms 1110 ofthe outer sleeve 1104 radially-outward, thereby disengaging the shelves1112 from the grooves 210 formed in the receiver member 200 andreleasing the receiver member from the instrument 1100. Once thereceiver member 200 is released, the instrument 1100 can be removed,leaving the receiver member securely coupled to the bone anchor 400.

As shown in FIGS. 11G-11H, the instrument 1100 can advantageouslyprevent the receiver member 200 from being released from the instrumentwhen the receiver member is not fully seated on the bone anchor 400. Inparticular, when the user presses the button 1116 in this scenario, thepush rod 1102 translates distally within the outer sleeve 1104. Becausethe bone anchor 400 is not fully seated within the receiver member 200,the projection 1122 of the release element 1106 does not contact thebone anchor 400 to limit distal travel of the release element relativeto the outer sleeve 1104, or contacts the bone anchor only aftersufficient distal travel of the release element occurs. Accordingly,when the push rod 1102 contacts the release element 1106, it simplypushes the release element distally, without the bearing surface 1120 ofthe push rod camming over the bearing surface 1126 of the releaseelement and without causing the arms 1124 of the release element todeflect radially-outward. Since the arms 1124 of the release element1106 do not move radially-outward, the arms 1110 of the outer sleeve1104 likewise do not move radially-outward, and the receiver member 200remains securely coupled to the distal end of the instrument 1100. Theforce required for the release element 1106 to eject the bone anchor 400from the receiver member 200 when the bone anchor is not fully seated inthe receiver member can be less than the force required to splay thearms 1110 of the outer sleeve 1104 outward. Accordingly, if the boneanchor 400 is only partially seated within the receiver member 200, therelease element 1106 can eject the bone anchor from the receiver memberinstead of releasing the receiver member from the instrument 1100.

The instrument 1100 can include a visual indicator to inform the user asto whether the bone anchor 400 is fully seated within the receivermember 200. For example, the release element 1106 can include a proximalextension (not shown) that is visible through a window formed in theouter sleeve 1104 or handle 1108 of the instrument 1100. The extensioncan be sized such that it is only visible through the window when therelease element 1106 is displaced proximally by a fully-seated boneanchor 400. Accordingly, when the release element 1106 is visiblethrough the window, it can indicate to the surgeon that the bone anchor400 is fully-seated within the receiver member 200.

Unilateral Instruments

As noted above, the bone anchor assembly 100 can facilitate unilateralattachment of instruments thereto. In particular, a unilateralinstrument can be attached to the receiver member 200 of the bone anchorassembly 100 at only one arm 202, 204 of the receiver member. Suchattachment can provide a number of advantages. For example, unilateralinstruments can have a lower profile such that they occupy less spacewithin a retractor, cannula, or minimally-invasive working channelformed in the patient, or facilitate use with less retraction or smallercannulas, reducing patient trauma. By way of further example, attachmentto only one side of the receiver member 200 can leave the other side ofthe receiver member open for attachment of other instruments, can leavea clear path for lateral rod insertion, or can improve visualization ofthe anatomy or surgical site.

Unilateral instruments can be used to introduce a head, to applycountertorque, to slide a retractor blade down to a bone surface, toattach a fulcrum for compression or distraction, to introduce a setscrew, to reduce a spinal rod (e.g., vertically, laterally, or both), orto perform various other surgical tasks.

FIGS. 12A-12F illustrate an exemplary unilateral attachment instrument1200 that can be used with the bone anchor assembly 100 described above.As shown, the instrument 1200 can include an elongated body 1202 and apivoting lock arm 1204.

The body 1202 can include proximal and distal ends 1202 p, 1202 d thatdefine a longitudinal proximal-distal axis A10. The proximal end 1202 pof the body 1202 can include a tube portion 1206 that is offset from theaxis A10, such that a central axis A11 of the tube is coaxial with thecentral axis A1 of a bone anchor assembly 100 when the instrument 1200is attached thereto. The tube 1206 can serve as an access channel orguide. For example, the tube 1206 can guide insertion of a driverinstrument therethrough to engage the bone anchor 400 and drive the boneanchor into bone. The tube 1206 can be omitted, or can be replaced witha handle or other feature. The interior of the tube 1206 can include athread, ratchet teeth, or other features for engaging instrumentsinserted therethrough. Such features can advantageously providemechanical advantage when performing various tasks with the instrument1200, such as rod reduction. The exterior of the tube 1206 can includeflats 1222 or an annular groove 1224 for engaging the tube with anotherinstrument, e.g., to apply a torque to the instrument, to attach theinstrument to frame or other device, and so forth.

The lock arm 1204 can be pivotally coupled to the body 1202 such thatthe distal end of the lock arm 1204 can pivot radially-inward andradially-outward relative to the body. The lock arm 1204 can bepivotally coupled to the body 1202 by a pivot pin 1208. The pivot pin1208 can be mounted at a point along the body 1202 that is intermediatethe proximal and distal ends 1202 p, 1202 d of the body. The lock arm1204 can include a release button 1210 for actuating the lock arm. Therelease button 1210 can be formed at a proximal end of the lock arm 1204as shown, such that pressing the release button inward towards the body1202 can cause the distal end of the lock arm to pivot radially-outwardaway from the body to a released position, and such that releasing thebutton can cause the distal end of the lock arm to pivot radially-inwardtowards the body to a locked position. The instrument 1200 can include abias element 1212 to bias the lock arm 1204 towards the locked positionor the released position. In the illustrated embodiment, a leaf spring1212 is disposed within the body 1202 and configured to bias the lockarm 1204 towards the locked position.

The distal end 1202 d of the body 1202 can define a recess 1214 sized toreceive an arm 202 or 204 of the receiver member 200 therein. The recess1214 and the arm 204 can have cross-sectional shapes that arecomplementary to one another such that, when engaged to one another, thearm cannot rotate relative to the recess or translate laterally relativeto the recess. The recess 1214 can be configured to grip or surroundmultiple sides of the arm 204 (e.g., at least two sides of the arm, atleast three sides of the arm, at least four sides of the arm, etc.). Asshown in FIG. 12E, the arm 204 and the recess 1214 can mate via adovetail connection. The recess 1214 can define a curved face 1216 thatforms a negative of the curved outer surface 214 of the arm 204. Therecess 1214 can also define first and second planar faces 1218 thatextend from the curved face 1216 and form a negative of the first andsecond engagement surfaces 218 of the arm 204. The first and secondfaces 1218 of the recess 1214 can extend at an oblique angle withrespect to a plane defined by the proximal-distal axis A1 of thereceiver member 200 and a central axis A2 of the rod-receiving recess206. The first and second faces 1218 of the recess 1214 can be angledtowards each other as the faces approach the proximal-distal axis A1 ofthe receiver member 200. As shown in FIG. 12E, the arm 204 can bereceived within or removed from the recess 1214 by translating the armlongitudinally with respect to the recess. The geometry of the recess1214 and the arm 204, however, can prevent the arm from rotatingrelative to the instrument 1200 or from translating laterally withrespect to the instrument when the arm is received in the recess 1214.

As shown in FIG. 12F, the distal end of the lock arm 1204 can include anengagement feature 1220 for preventing or limiting longitudinal movementof the instrument 1200 relative to the arm 204 of the receiver member200. The engagement feature 1220 can include a shelf or ridge thatprojects radially-inward from the lock arm 1204 to selectively engage acorresponding arcuate groove 210 formed in the arm of the receivermember 200.

In use, an arm 202, 204 of the receiver member 200 can be insertedproximally into the recess 1214 and the lock arm 1204 can be engagedwith the groove 210 formed in the arm. When coupled to the instrument1200 in this manner, the receiver member 200 can be locked to theinstrument, such that the receiver member cannot rotate or translate inany direction with respect to the instrument. The instrument 1200 canthus provide a stable platform for unilateral attachment to a receivermember or other head 200 of a bone anchor assembly 100.

A number of surgical steps can be facilitated by a unilateral attachmentto the receiver head. FIG. 12G illustrates an exemplary method of usingthe unilateral attachment instrument 1200 to assemble a receiver member200 to a bone anchor 400 previously implanted in a vertebra V1. Thereceiver member 200 can be attached to the instrument 1200 as describedabove, and then lowered distally onto the head 402 of the bone anchor400. The user can apply a distal pushing force to the instrument 1200 topush the receiver member 200 onto the bone anchor 400 and form anassembled bone anchor assembly 100A. Once assembled, the instrument 1200can be left in place, as shown with respect to a second bone anchorassembly 100B. Use of the unilateral attachment instrument 1200 can makeit easier for the user to visualize the bone anchor 400 as the receivermember 200 is being advanced into the patient.

FIG. 12H illustrates an exemplary method of using a unilateralattachment instrument in connection with introduction of a spinal rod.As shown, first and second bone anchor assemblies 100A, 100B can beimplanted in respective first and second vertebrae V1, V2. Unilateralattachment instruments 1200A, 1200B can be coupled to each of the boneanchor assemblies 100A, 100B. A rod inserter 1226 can be used tointroduce a spinal rod R1 coupled thereto into the rod receivingrecesses of the bone anchor assemblies 100A, 100B. Introduction of therod R1 can be facilitated by the use of the unilateral attachmentinstruments 1200A, 1200B, since one side of the receiver members 200A,200B is left open such that motion of the rod into alignment with therecesses can include a lateral component. With a typical bilateralinstrument, the motion of the rod would have to be limited toproximal-distal movement and longitudinal movement. In a typical MISprocedure with a bilateral instrument, the free end of the rod wouldneed to be guided beneath the skin into the narrow channel between theopposed arms of the bilateral instrument. With a unilateral instrument,tunneling of the rod does not need to be as precise, since the rod canbe moved laterally into alignment with the rod-receiving recess of thesecond bone anchor assembly.

FIG. 12I illustrates an exemplary method of using a unilateralattachment instrument in connection with inserting a set screw. Asshown, first and second bone anchor assemblies 100A, 100B can beimplanted in respective first and second vertebrae V1, V2. Unilateralattachment instruments 1200A, 1200B can be coupled to each of the boneanchor assemblies 100A, 100B. A spinal rod R1 can be positioned inalignment with the rod-receiving recesses of the bone anchor assemblies100A, 100B, for example using a rod introduction method of the typedescribed above with respect to FIG. 12H. The instrument 1200B can guideinsertion of a set screw 102 and a set screw driver instrument 1228. Thedriver shaft 1228 can be rotated within the instrument 1200B to threadthe set screw 102 into or out of the receiver member 200B, e.g., forfinal tightening of a spinal rod R1 to the bone anchor assemblies 100A,100B.

FIG. 12J illustrates an exemplary method of using a unilateralattachment instrument in connection with reducing a spinal rod andinserting a set screw. Reduction of the rod R1 into the rod seats of thereceiver members 200A, 200B can be achieved by inserting a reductiontool 1232 through a working channel of the unilateral attachmentinstrument 1200A. The tubular extension 1206 of the instrument 1200A canguide insertion of the reduction tool 1232. The reduction tool 1232 canbe threadably engaged or otherwise coupled with the tubular extension1206, such that the tool can be rotated within the tubular extension toreduce the rod R1. The reduction tool 1232 can define a working channelfor guiding insertion of a set screw 102 and a set screw driverinstrument 1230. The driver shaft 1230 can be rotated within thereduction tool 1232 to thread the set screw 102 into or out of thereceiver member 200A, e.g., for final tightening of a spinal rod R1 tothe bone anchor assemblies 100A, 100B.

As shown in FIG. 12K, the instrument 1200A can be used to applycountertorque when tightening or loosening the set screws 102. Theinstrument 1200A can include one or more flats 1222 at a proximal end ofthe instrument that can be gripped with an open-end wrench or other tool1234 to provide a mechanical advantage to the user in applying acountertorque force to the instrument while the set screw driver 1230 isrotated within the instrument.

While not shown, it will be appreciated that the unilateral instrumentcan serve as a platform for any of a number of other surgical steps. Forexample, unilateral instruments can be used with a distraction device todistract first and second vertebrae. In particular, first and secondinstruments can be coupled to respective first and second bone anchorassemblies implanted respectively in the first and second vertebrae. Thedistraction device can be engaged with the instruments to apply adistraction force thereto, thereby distracting the vertebrae.

As another example, unilateral instruments can be used with acompression device to compress first and second vertebrae. Inparticular, first and second instruments can be coupled to respectivefirst and second bone anchor assemblies implanted respectively in thefirst and second vertebrae. The compression device can be engaged withthe instruments to apply a compression force thereto, therebycompressing the vertebrae.

As another example, unilateral instruments can be used to perform aderotation maneuver. In particular, first and second instruments can becoupled to respective first and second bone anchor assemblies implantedrespectively in first and second vertebrae. The first and secondinstruments can be pushed in opposite directions to rotate one vertebrawith respect to the other vertebra. The instruments can include featuresfor coupling the instruments to a derotation frame.

Bone Anchor Assemblies with Inserts

FIGS. 13A-13K illustrate an exemplary embodiment of a bone anchorassembly 1300. Except as indicated below and as will be readilyappreciated by a person having ordinary skill in the art in view of thepresent disclosure, the structure and operation of the bone anchorassembly 1300 is substantially the same as that of the bone anchorassembly 100 described above. For example, the bone anchor assembly 1300can include a collet 300, a shank or bone anchor 400, and a closuremechanism or set screw 102, all of the type described above. The boneanchor assembly 1300 can also include a receiver member 200′ which canbe similar to the receiver member 200 described above, but can include aseparate retaining ring or insert 1302. During assembly, the collet 300can be inserted into the receiver member 200′ and, thereafter, theinsert 1302 can be secured to the receiver member to retain the colletwithin the receiver member. Use of a separate insert 1302 can allow thecollet 300 to be assembled to the receiver member 200′ without deformingor deflecting the fingers 316 of the collet 300 as the collet is loadedinto the receiver member. This can advantageously reduce the risk of thecollet fingers 316 being damaged during assembly.

The insert 1302 can be a ring-shaped body having an inner surface, anouter surface, and a central opening extending therethrough. The centralopening can be large enough to allow the head 402 of the shank 400 topass therethrough along the axis A1, but small enough to prevent thecollet 300 from passing distally through the insert 1302. The centralopening of the insert 1302 can have a diameter that is less than aresting outer diameter of the fingers 316 of the collet 300.

The insert 1302 can be secured to the receiver member 200′ in variousways. For example, as shown in FIGS. 13A-13F, the outer surface of theinsert 1302 can include a ridge 1304 that extends radially-outwardtherefrom. An inner surface of the receiver member 200′ can include acounterpart groove 1306 in which the ridge 1304 can be received tosecure the insert 1302 to the receiver member. When the ridge 1304 isreceived within the groove 1306, the insert 1302 can be prevented frommoving proximally or distally along the axis A1 relative to the receivermember 200′. The insert 1302 can be radially-expandable and/orradially-collapsible to facilitate insertion of the ridge 1304 into thegroove 1306 during assembly. For example, the insert 1302 can include acut 1308 such that the insert forms a C-clip as shown. In otherarrangements, the insert 1302 can include one or more slits, webbedportions, or other features for allowing expansion and/or contraction ofthe insert. It will be appreciated that the positioning of the ridge1304 and the groove 1306 can be reversed, such that the groove is formedin the insert 1302 and the ridge is formed in the receiver member 200′.While a continuous circumferential ridge 1304 and groove 1306 are shown,in other arrangements the insert 1302 can include one or more discreteprojections configured to be received within a corresponding one or morediscrete pockets of the receiver member 200′ to retain the inserttherein.

As another example, as shown in FIGS. 13G-13K, the outer surface of theinsert 1302 can include a thread 1310 that engages with a correspondingthread 1312 formed in the inner surface of the receiver member 200′.Accordingly, rotation of the insert 1302 about the axis A1 relative tothe receiver member 200′ can be effective to advance or retract theinsert into the receiver member along the axis A1. In some embodiments,the insert 1302 can be threadably advanced into the receiver member 200′until a proximal end of the insert contacts and bears against adistal-facing shoulder 1314 formed in the receiver member. Adistal-facing surface of the insert 1302, e.g., at the terminal distalend of the insert, can include a drive feature 1316 to facilitateapplication of torque to the insert. In one arrangement, as shown inFIG. 13K, the drive feature can be one or more female recesses 1316sized to receive a corresponding male drive feature of a driverinstrument. In other arrangements, the drive feature can be a male drivefeature that projects distally from the insert 1302. The male drivefeature can be configured to break off from the insert 1302 when apre-determined threshold force, e.g., a predetermined threshold torque,is applied thereto. Accordingly, the insert 1302 can be tightened to thereceiver member 200′ until the male drive feature breaks off, indicatingto the user that the insert is tightened sufficiently and, optionally,preventing subsequent removal of the insert from the receiver member.

While threaded and snap-ring engagements are shown for attaching theinsert 1302 to the receiver member 200′, it will be appreciated that anyof a variety of other attachment types can be used instead or inaddition, such as swaging, staking, gluing, welding, and so forth.

Some or all of the working surfaces of the cavity 222 of the receivermember 200′ can be defined by the insert 1302. In FIGS. 13A-13F, theupper portion 224 of the cavity 222 is defined partially by the receivermember 200′ and partially by the insert 1302. In particular, thefrustoconical or substantially frustoconical part of the upper portion224 is formed by the receiver member 200′ and the spherical orsubstantially spherical seat 230 is formed by the insert 1302. Themiddle and lower portions 226, 228 of the cavity 222 are defined by theinsert 1302. In FIGS. 13G-13K, the upper, middle, and lower portions224, 226, 228 of the cavity 222 are all defined by the inner surface ofthe insert 1302.

As noted above, the bone anchor assembly 1300 can be assembled byloading the collet 300 into the distal end of the receiver member 200′and then attaching the insert 1302 to the receiver member to retain thecollet therein. Once assembled, use of the bone anchor assembly 1300 canbe substantially the same as that of the bone anchor assembly 100described above. As shown in FIGS. 13D and 13H, the head 402 of theshank 400 can be loaded into the distal end of the insert 1302 andpassed proximally therethrough into the receiver member 200′. An axialforce can be applied to the receiver member 200′, causing the head 402of the shank 400 to push the collet fingers 316 into the upper portion224 of the cavity 222, where the collet fingers are allowed to radiallyexpand and allow passage of the head of the shank into the collet, asshown in FIGS. 13E and 13I. The collet fingers 316 can constrain theshank head 402 within the receiver member 200′. Diametrical interferencebetween the shank head 402 and the collet fingers 316 inner sphere cancreate drag between the two components, e.g., for provisionalpositioning of the bone anchor assembly 1300 and to prevent flopping. Arod R1 and a set screw 102 can be installed into the receiver member200′ as shown in FIGS. 13F and 13J. Subsequent rotation of the set screw102 can draw the receiver member 200′ upward relative to the rod R1 andthe collet 300, thereby wedging the collet fingers 316 between the shankhead 402 and the insert 1302. The insert 1302 and the collet fingers 316can be configured to constrain the shank head 402 in the receiver member200′, thereby creating a polyaxial locking mechanism. The insert 1302inner surface can be spherical to accept collet fingers 316 with anouter spherical shape to facilitate remobilization of polyaxial motionupon set screw removal.

Bone Anchor Assemblies with Compression Caps

FIGS. 14A-14K illustrate an exemplary embodiment of a bone anchorassembly 1400. Except as indicated below and as will be readilyappreciated by a person having ordinary skill in the art in view of thepresent disclosure, the structure and operation of the bone anchorassembly 1400 is substantially the same as that of the bone anchorassemblies 100, 1300 described above. For example, the bone anchorassembly 1400 can include a receiver member 200′ with a retaining ringor insert 1302, a shank or bone anchor 400, and a closure mechanism orset screw 102, all of the type described above. The bone anchor assembly1400 can also include a multi-component collet 300′. The collet 300′ caninclude a compression cap 1402 and a collet ring 1404. The compressioncap 1402 can be axially-translatable relative to the collet ring 1404.The compression cap 1402 can contact and bear against the spherical head402 of the shank 400 when the construct is tightened (e.g., when aspinal rod R1 is secured to the bone anchor assembly 1400 by a set screw102). Thus, when the construct is locked, resistance to polyaxialmovement of the shank 400 relative to the receiver member 200′ can beprovided at both (i) distal portions of the shank head 402 via wedgedcollet fingers 316 and (ii) proximal portions of the shank head via thecompression cap 1402. The compression cap 1402 can provide a load paththat bears down onto the proximal-most portion of the shank head 402,which may provide increased poly-slip performance as compared to a loadpath that runs exclusively through the collet fingers 316. Thecompression cap 1402 can also augment the resistance to polyaxialmovement provided by the wedged collet fingers 316 by increasing thesurface area of the collet 300′ that is in contact with the shank head402. The illustrated arrangement may provide enhanced poly-slipperformance as compared to arrangements that employ only a compressioncap, as the wedged collet fingers 316 can provide locking that is moreconsistent and largely independent of the angle of the shank 400relative to the receiver member 200′.

During assembly, the collet 300′ can be inserted into the receivermember 200′ and, thereafter, the insert 1302 can be secured to thereceiver member to retain the collet within the receiver member. Use ofa separate insert 1302 can allow the collet 300′ to be assembled to thereceiver member 200′ without deforming or deflecting the fingers 316 ofthe collet 300′ as the collet is loaded into the receiver member. Thiscan advantageously reduce the risk of the collet fingers 316 beingdamaged during assembly.

The bone anchor assembly 1400 can be modular such that any of a varietyof heads 200′ can be coupled to any of a variety of bone anchors 400,and such that the assembly 1400 can be fit together in situ. The boneanchor 400 can be bottom loaded into the receiver member 200′ and can becaptured by the collet 300′ to retain the bone anchor within thereceiver member while still allowing relative motion therebetween. Theset screw 102 can be tightened to wedge the collet 300′ between the head402 of the bone anchor 400 and the receiver member 200′, and to urge thecompression cap 1402 onto the head of the bone anchor, thereby lockingthe relative position of the bone anchor and the receiver member. Theset screw 102 can also be effective to lock a spinal rod R1 or otherimplant to the bone anchor assembly 1400.

In use, the bone anchor 400 can be driven into bone without the head200′ being attached thereto. This can result in a lower profile initialconstruct and allow the bone anchor 400 to be placed before other stepsof the procedure are performed, such as exposing the neural elements,removing the facets and disc for fusion, and so forth. As a result,anatomical reference points can be preserved and can be used whentargeting bone anchor 400 insertion. Also, the lower profile can providemore access to the surgical site for the user. The bone anchor 400 canalso be used as a platform for other manipulations, such as distraction,compression, derotation, soft tissue retraction, and the like. Theassembly 1400 can also be implanted in the patient in a pre-assembledstate.

FIGS. 14C and 14D illustrate the head or receiver member 200′ in detail.The receiver member 200′ can include proximal and distal ends 200 p, 200d that define a central proximal-distal axis A1. The proximal end 200 pof the receiver member 200′ can include a pair of spaced apart arms 202,204 that define a rod-receiving recess 206 therebetween. Therod-receiving recess 206 can have a central axis A2. The rod-receivingrecess 206 can be open in a proximal direction, such that a rod R1 canbe inserted into the recess by moving the rod distally with respect tothe receiver member 200′. The inner surfaces of each of the arms 202,204 can be configured to mate with the set screw 102. For example, theinner surfaces of the arms 202, 204 can include threads that correspondto external threads formed on the set screw 102. Accordingly, rotationof the set screw 102 with respect to the receiver member 200′ about theaxis A1 can be effective to translate the set screw with respect to thereceiver member axially along the axis A1. Each of the arms 202, 204 canextend from a base portion 208 of the receiver member 200′ to a freeend.

The arms 202, 204 can include features, such as recesses, dimples,notches, projections, or the like, to facilitate coupling of thereceiver member 200′ to various instruments. For example, as describedabove with respect to the receiver member 200, the receiver member 200′can include a “top notch” feature and/or a unilateral attachmentfeature. Alternatively, or in addition, the receiver member 200′ caninclude a blind hole, through hole, recess, or opening 220 formed in anexterior sidewall thereof, e.g., for engagement with a correspondingprojection of an instrument, such as a rocker fork reduction instrument,to facilitate coupling of the instrument to the receiver member 200′. Inthe illustrated arrangement, a “bow-tie” type recess 220 is formed ineach of the arms 202, 204 of the receiver member 200′.

The base portion 208 of the receiver member 200′ can define an interiorcavity 222 in which the collet 300′ and the head 402 of the bone anchor400 can be received. While any of a variety of cavity shapes can beused, the illustrated cavity 222 includes an upper, proximal portion224, a middle portion 226, and a lower, distal portion 228, as shown inFIG. 14C.

The upper portion 224 of the cavity 222 can be cylindrical orsubstantially cylindrical about the axis A1. The upper portion 224 ofthe cavity can receive a proximal body portion 1406 of the collet ring1404 in a snug fit. For example, the upper portion 224 of the cavity canhave an inside diameter that is closely matched to the outside diameterof the proximal body portion 1406 of the collet ring 1404, e.g., +/−5%.This can limit or prevent “slop” in the assembly 1400 prior to lockingand can help resist toggle or deformation of the collet 300′ within thereceiver member 200′, before, during, or after locking. In someembodiments, a cylinder-to-cylinder contact or constraint can be formedbetween the collet ring 1404 and the upper portion 224 of the cavity222. The middle portion 226 of the cavity can be frustoconical orsubstantially frustoconical about the axis A1. The middle portion 226 ofthe cavity can provide a relief zone to accommodate radially-outwardexpansion of the collet fingers 316 when the head 402 of the shank 400is introduced into the collet ring 1404. The lower portion 228 of thecavity 222 can include a spherical or substantially spherical seat 234that faces in a proximal direction. The seat 234 can form a bearingsurface against which the collet fingers 316 can be wedged when theassembly 1400 is locked. In some embodiments, the seat 234 can beconical and/or tapered. The cavity 222 can be entirely defined byinterior surfaces of a unitary or monolithic receiver member or, asshown, at least a portion of the cavity can be defined by a retainingring or insert 1302 that is separate from the receiver member 200′. Inthe illustrated arrangement, the spherical seat 234 is defined by theinterior surface of the retaining ring 1302.

The receiver member 200′ can include features for restricting orpreventing motion of the collet 300′ with respect to the receivermember. For example, the receiver member 200′ can include features forlimiting proximal-distal travel of the collet 300′, or for limiting orpreventing rotation of the collet. In the illustrated embodiment, thereceiver member 200′ includes diametrically-opposed flats 240 thatengage corresponding flats 308 of the compression cap 1402 to preventrotation of the compression cap relative to the receiver member. Thiscan help ensure that a rod slot 306 of the compression cap 1402 remainsaligned with the rod slot 206 of the receiver member 200′. Theillustrated anti-rotation feature may be easier to manufacture than thekeyway and wing arrangement described above, though in some embodimentsthe bone anchor assembly 1400 can include a keyway and wing arrangement.The flats 240 can allow the compression cap 1402 to translate along theaxis A1 with respect to the receiver member 200′ while restricting orpreventing rotation of the compression cap about the axis A1 withrespect to the receiver member. Proximal travel of the compression cap1402 within the receiver member 200′ can be limited by engagementbetween a proximal-facing surface 1408 of the compression cap and adistal-facing shoulder 242 formed at the roof of the cavity 222. Theshoulder 242 can also limit proximal travel of the collet ring 1404within the receiver member 200′. The shoulder 242 can be obliquelyangled with respect to the central axis A1, which can facilitatemanufacturing of the receiver member 200′ by allowing the shoulder 242to be machined with a pointed-tip drill bit. The obliquely-angledshoulder 242 can also allow more material to be retained whenmanufacturing the receiver member 200′, thickening the sidewall of thereceiver member in an area that may be important for resisting splayingof the receiver member arms 202, 204 when the set screw 102 istightened.

The collet 300′ can include a compression cap 1402 (shown in detail inFIG. 14E) and a collet ring 1404 (shown in detail in FIG. 14F). Thecompression cap 1402 can be movably-coupled to the collet ring 1404. Forexample, the compression cap 1402 can be telescopically-received withina central opening of the collet ring 1404. The compression cap 1402 andthe collet ring 1404 can be positioned within the cavity 222 formed inthe receiver member 200′. The compression cap 1402 and the collet ring1404 can be independently longitudinally translatable within the cavity222, along the axis A1. The compression cap 1402 can be rotatablerelative to the collet ring 1404 about the axis A1. The compression cap1402 can be limited or prevented from rotating relative to the colletring 1404 about the axis A1. For example, the compression cap 1402 andthe collet ring 1404 can include interlocking ridge and groove featuresto limit rotation therebetween while still allowing relative axialtranslation.

The compression cap 1402 can be generally cylindrical with first andsecond arms 302, 304 extending in a proximal direction to respectivefree ends of the arms. The first and second arms 302, 304 can be alignedwith the first and second arms 202, 204 of the receiver member 200′ suchthat a recess 306 defined therebetween is aligned with the rod-receivingrecess 206. Accordingly, the rod R1 can be simultaneously cradledbetween the arms 302, 304 of the compression cap 1402 and the arms 202,204 of the receiver member 200′ when the rod is disposed in therod-receiving recess 206.

The compression cap 1402 can include a mating feature configured tolimit or prevent certain movement of the compression cap with respect tothe receiver member 200′. For example, the compression cap 1402 caninclude opposed flats 308 formed in the outer surfaces of the arms 302,304. The flats 308 can be aligned with and can contact the correspondingflats 240 described above to allow the compression cap 1402 to translatewithin the receiver member 200′ but to limit or prevent rotation of thecompression cap 1402 relative to the receiver member. While multipleflats 308 are shown, the compression cap 1402 can include only a singleflat in some embodiments or can include more than two flats.

The compression cap 1402 can include a radial projection 1410. Theprojection 1410 can be formed at or adjacent to a distal end of thecompression cap 1402. The projection 1410 can define a proximal-facingshoulder 1408 for contacting the shoulder 242 of the receiver member200′ to limit proximal translation of the compression cap 1402 relativeto the receiver member along the axis A1. The proximal-facing shoulder1408 can be obliquely angled with respect to the axis A1. For example,the proximal-facing shoulder 1408 can be conical, spherical, stepped,tapered, etc. The proximal-facing shoulder 1408 can be planar and canextend perpendicular to the axis A1. The projection 1410 can define adistal-facing shoulder 1412 for contacting a proximal-facing shoulder1414 of the collet ring 1404 to limit distal translation of thecompression cap 1402 relative to the collet ring along the axis A1. Thedistal-facing shoulder 1412 can be obliquely angled with respect to theaxis A1. For example, the distal-facing shoulder 1412 can be conical,spherical, stepped, tapered, etc. The distal-facing shoulder 1412 can beplanar and can extend perpendicular to the axis A1. The projection 1410can define a cylindrical outer surface 1416 configured to mate with acylindrical inner surface 1418 of the collet ring 1404, as describedbelow.

The compression cap 1402 can define a central opening 310 that extendscompletely through the compression cap along the axis A1. The opening310 can be sized to receive a guide wire or needle therethrough, or toreceive a driver therethrough for engaging the drive interface of thebone anchor 400.

The compression cap 1402 can include a distal-facing bearing surface1420 configured to contact and bear against the head 402 of the boneanchor 400, e.g., to lock polyaxial movement of the bone anchor relativeto the receiver member 200′. The bearing surface 1420 can be sphericalor substantially spherical. The bearing surface 1420 can include one ormore teeth or ridges, and/or various other surface coatings, treatments,or geometries to enhance grip between the compression cap 1402 and thehead 402 of the bone anchor 400. The bearing surface 1420 can bespherical and can have a diameter slightly less than the diameter of theshank head 402 sphere. As a result, when locked, a ring-shaped linecontact can be formed between the compression cap 1402 and the head 402,which may enhance the poly-slip performance of the assembly 1400. Thebearing surface 1420 can also serve to limit proximal travel of theshank 400 relative to the receiver member 200′ during assembly. This canhelp guard against a situation where the shank 400 is inserted soforcefully into the receiver member 200′ as to risk the head 402 passingproximally beyond the collet fingers 316. In such a situation, the head402 would first contact the bearing surface 1420 and would thereby beprevented from passing proximally beyond the collet fingers 316.

The compression cap 1402 can include features for engaging thecompression cap with an instrument to manipulate the compression cap,e.g., as described above with respect to the collet 300.

The collet ring 1404 can include a generally-cylindrical proximal body1406. The collet ring 1404 can define a central opening 310 that extendscompletely through the collet ring along the axis A1. The opening 310can be sized to receive a guide wire or needle therethrough, or toreceive a driver therethrough for engaging the drive interface of thebone anchor 400. The opening can further be configured to receive thecompression cap 1402 therein, such that the compression cap is coaxialwith, and telescopically slidable with respect to, the collet ring 1404.A proximal-facing shoulder 1414 can be defined within the opening 310 tolimit distal travel of the compression cap 1402 relative to the colletring 1404.

The collet ring 1404 can include one or more slits formed therein todefine a plurality of distally-extending fingers 316. The fingers 316can be configured to deform radially-inward and/or radially-outward froma resting position. The fingers 316 can have resilient properties suchthat, when deformed from their resting position, the fingers are biasedtowards the resting position.

While the illustrated collet ring 1404 includes six fingers 316, it willbe appreciated that the collet ring can include any number of fingers,e.g., zero, one, two, three, four, five, six, seven, eight, or more.Including a larger number of fingers 316 can result in each individualfinger being narrower in width for a given size collet ring 1404, makingthe finger easier to deflect during assembly.

The slits can have an expanded or T-shaped proximal end to provide arelief and allow the fingers 316 to deform to a greater degree with lesseffort or without breaking. The fingers 316 can include areduced-thickness region 318 adjacent their proximal end to encouragebending of the fingers at a predetermined bend zone. The distal-mostends of the fingers 316 can include a curved, tapered, angled, or rampedsurface 320 to provide a lead in for entry of the head 402 of the boneanchor 400 and for wedging the collet fingers between the head of thebone anchor and the receiver member 200′. The lead-in surface 320 canface substantially radially-inward. The inner surfaces of the fingers316 can be spherical or substantially spherical. The outer surfaces ofthe fingers 316 can likewise be spherical or substantially spherical. Insome embodiments, the inner surfaces of the fingers 316 each formsections of a common sphere.

The fingers 316 can have a resting diameter greater than that of theopening defined by the retaining ring 1302, such that the collet ring1404 is retained in the cavity 222. It will be appreciated that theretaining ring 1302 can allow the collet ring 1404 to be retained withinthe cavity 222 without necessarily requiring swaging. Swaging is acommon manufacturing process that involves permanent materialdeformation to retain one component within another. Deformation ofmaterial during the swaging process is less predictable than traditionalmachining processes and can require special manufacturing controls,which can increase manufacturing cost. The illustrated bone anchorassembly 1400 can thus be easier and less expensive to manufacture thanbone anchor assemblies that require swaging. While swaging is notnecessarily required, in some embodiments, swaging can be used to retainthe collet 300′ within the cavity 222 or to augment the retention of thecollet.

The fingers 316 can be deformed from their resting position as the head402 of the shank 400 is loaded into the distal end of the collet ring1404. The receiver member 200′ and the collet ring 1404 can be assembledto the head 402 of the shank 400 by applying a distal axial force to thereceiver member over the head of the shank. The head 402 of the shank400 can bear against the distal lead-in surfaces 320 of the fingers 316to deform the fingers radially-outward from their resting position. Oncethe head 402 of the shank 400 is advanced far enough into the colletring 1404, the fingers 316 can return towards their resting position,capturing the head of the shank therein to retain the shank within thecollet 300′ and, by extension, within the receiver member 200′. Whencaptured within the collet ring 1404, and before the collet is lockeddown within the receiver member 200′, the shank 400 can still be free topivot with respect to the collet ring and to rotate about the axis A1relative to the collet ring. The collet ring 1404 can apply a drag forceto the head 402 of the bone anchor 400, e.g., due to a lightinterference fit between the collet fingers 316 and the head of the boneanchor. The drag force can maintain the relative position between thereceiver member 200′ and the bone anchor 400 prior to locking theconstruct, e.g., during provisional positioning of the assembly 1400, toprevent the receiver member from “flopping” over. The drag force canthus prevent unintended movement prior to locking the assembly 1400,while still allowing free movement when intended by the user.

Once assembled to the head 402 of the shank 400, rod insertion and setscrew 102 locking can be effective to drive the collet ring 1404distally with respect to the receiver member 200′, wedging the colletfingers 316 between the head of the shank and the seat 234 of theretaining ring 1302, thereby locking movement of the shank with respectto the receiver member.

The insert 1302 is shown in detail in FIGS. 14C and 14G. The insert 1302can be a ring-shaped body having an inner surface, an outer surface, anda central opening extending therethrough. The central opening can belarge enough to allow the head 402 of the shank 400 to pass therethroughalong the axis A1, but small enough to prevent the collet 300′ frompassing distally through the insert 1302. The central opening of theinsert 1302 can have a diameter that is less than a resting outerdiameter of the fingers 316 of the collet 300′.

The insert 1302 can be secured to the receiver member 200′ in variousways, as described in detail above. For example, as shown, the outersurface of the insert 1302 can include a ridge 1304 that extendsradially-outward therefrom. An inner surface of the receiver member 200′can include a counterpart groove 1306 in which the ridge 1304 can bereceived to secure the insert 1302 to the receiver member. When theridge 1304 is received within the groove 1306, the insert 1302 can beprevented from moving proximally or distally along the axis A1 relativeto the receiver member 200′. The insert 1302 can be radially-expandableand/or radially-collapsible to facilitate insertion of the ridge 1304into the groove 1306 during assembly. For example, the insert 1302 caninclude a cut 1308 such that the insert forms a C-clip as shown. Inother arrangements, the insert 1302 can include one or more slits,webbed portions, or other features for allowing expansion and/orcontraction of the insert. It will be appreciated that the positioningof the ridge 1304 and the groove 1306 can be reversed, such that thegroove is formed in the insert 1302 and the ridge is formed in thereceiver member 200′. While a continuous circumferential ridge 1304 andgroove 1306 are shown, in other arrangements the insert 1302 can includeone or more discrete projections configured to be received within acorresponding one or more discrete pockets of the receiver member 200′to retain the insert therein.

The set screw 102 can include an exterior thread configured to mate withthe interior threads formed on the arms 202, 204 of the receiver member200′. The threaded engagement can allow the set screw 102 to be advancedor retracted along the axis A1 with respect to the receiver member 200′by rotating the set screw about the axis A1. The set screw 102 caninclude a driving interface configured to receive a driver for applyinga rotational force to the set screw about the axis A1. The distalsurface of the set screw 102 can be configured to contact and bearagainst a rod R1 disposed in the rod-receiving recess 206 to lock therod to the assembly 1400. When tightened against the rod R1, the setscrew 102 can prevent the rod from translating relative to the receivermember 200′ along the axis A2 and/or from rotating with respect to thereceiver member about the axis A2. While a set screw 102 is shown, itwill be appreciated that other locking elements can be used instead oraddition, such as a closure cap that advances and locks by quarter-turnrotation, a closure cap that slides in laterally without rotating, a nutthat threads onto an exterior of the receiver member 200′, and so forth.In some embodiments, a dual set screw can be used. The dual set screwcan include an outer set screw that bears against the arms 302, 304 ofthe compression cap 1402 to lock the polyaxial movement of the shank 400relative to the receiver member 200′. The dual set screw can alsoinclude an inner set screw threadably mounted in an opening formed inthe outer set screw. The inner set screw can be tightened to bearagainst the rod R1 and to lock the rod to the receiver member 200′.

As shown in FIG. 14B, the shank or bone anchor 400 can include aproximal head portion 402 and a distal shaft portion 404 and can definea central longitudinal bone anchor axis A3.

As noted above, the bone anchor assembly 1400 can be assembled byloading the collet 300′, including the compression cap 1402 and thecollet ring 1404, into the distal end of the receiver member 200′ andthen attaching the insert 1302 to the receiver member to retain thecollet therein. Once assembled, use of the bone anchor assembly 1400 canbe substantially the same as that of the bone anchor assemblies 100,1300 described above. As shown in FIG. 14C, the head 402 of the shank400 can be loaded into the distal end of the insert 1302 and passedproximally therethrough into the receiver member 200′. An axial forcecan be applied to the receiver member 200′, causing the head 402 of theshank 400 to push the collet fingers 316 into the middle portion 226 ofthe cavity 222, where the collet fingers are allowed to radially expandand allow passage of the head of the shank into the collet ring 1404.The collet fingers 316 can constrain the shank head 402 within thereceiver member 200′. Diametrical interference between the shank head402 and the collet fingers 316 inner sphere can create drag between thetwo components, e.g., for provisional positioning of the bone anchorassembly 1400 and to prevent flopping. A rod R1 and a set screw 102 canbe installed into the receiver member 200′. Subsequent rotation of theset screw 102 can draw the receiver member 200′ upward relative to therod R1 and the head 402 of the shank 400, which can be implanted inbone. This movement can wedge the collet fingers 316 between the shankhead 402 and the insert 1302 and force the compression cap 1402 againstthe shank head. The insert 1302, the collet fingers 316, and thecompression cap 1402 can be configured to constrain the shank head 402in the receiver member 200′, thereby creating a polyaxial lockingmechanism. The insert 1302 inner surface can be spherical to acceptcollet fingers 316 with an outer spherical shape to facilitateremobilization of polyaxial motion upon set screw removal.

FIGS. 14H-14K illustrate the bone anchor assembly 1400 in variousexemplary states of component positioning.

In FIG. 14H, the compression cap 1402 and the collet ring 1404 are eachshown at their respective limits of proximal travel within the receivermember 200′ along the axis A1. In this state, the proximal end of thecollet ring 1404 and the proximal-facing shoulder 1408 of thecompression cap 1402 contact the distal-facing shoulder 242 of thereceiver member 200′.

In FIG. 14I, the compression cap 1402 is shown at its limit of proximaltravel within the receiver member 200′ along the axis A1 and the colletring 1404 is shown at its limit of distal travel within the receivermember 200′ along the axis A1. In this state, the collet fingers 316contact the seat 234 of the retaining ring 1302 to prevent the colletring 1404 from falling distally out of the receiver member 200′. Asshown, in this state, the axial spacing between the various shouldersand stop surfaces of the assembly 1400 can be selected such that anaxial overlap always exists between the compression cap 1402 and thecollet ring 1404, e.g., such that at least a portion of the compressioncap remains disposed within the central opening of the collet ring atall times. This can help prevent inadvertent separation, toggling,jamming, etc. of the internal components of the assembly 1400.

In FIG. 14J, the compression cap 1402 and the collet ring 1404 are eachshown at their respective limits of distal travel within the receivermember 200′ along the axis A1. In this state, the collet fingers 316contact the seat 234 of the retaining ring 1302 to prevent the colletring 1404 from falling distally out of the receiver member 200′. Also inthis state, the distal-facing shoulder 1412 of the compression cap 1402contacts the proximal-facing shoulder 1414 of the collet ring 1404 tolimit distal travel of the compression cap.

In FIG. 14K, the compression cap 1402 and the collet ring 1404 are shownin a typical locking position in which the assembly 1400 is locked toprevent polyaxial movement between the shank 400 and the receiver member200′. In this state, the collet fingers 316 are wedged between the head402 of the shank 400 and the seat 234 of the retaining ring 1302 toapply a locking force to a distal region of the shank head. Also in thisstate, the distal-facing bearing surface 1420 of the compression cap1402 is compressed against the shank head 402 to apply a locking forceto a proximal region of the shank head. The proximal-facing shoulder1414 of the collet ring 1404 can be formed at sufficient depth withinthe central opening of the collet ring to ensure that the compressioncap 1402 contacts the shank head 402 first during locking, beforebottoming-out within the collet ring.

It should be noted that any ordering of method steps expressed orimplied in the description above or in the accompanying drawings is notto be construed as limiting the disclosed methods to performing thesteps in that order. Rather, the various steps of each of the methodsdisclosed herein can be performed in any of a variety of sequences. Inaddition, as the described methods are merely exemplary embodiments,various other methods that include additional steps or include fewersteps are also within the scope of the present disclosure.

While the methods illustrated and described herein generally involveattaching spinal rods to multiple vertebrae, it will be appreciated thatthe devices and methods herein can be used with various other types offixation or stabilization hardware, in any bone, in non-bone tissue, orin non-living or non-tissue objects. The bone anchor assemblies andother implants disclosed herein can be fully implanted, or can be usedas part of an external fixation or stabilization system. The devices andmethods disclosed herein can be used in minimally-invasive surgeryand/or open surgery.

The devices disclosed herein and the various component parts thereof canbe constructed from any of a variety of known materials. Exemplarymaterials include those which are suitable for use in surgicalapplications, including metals such as stainless steel, titanium,cobalt-chromium, titanium-molybdenum, or alloys thereof, polymers suchas PEEK, ceramics, carbon fiber, and so forth. The various components ofthe devices disclosed herein can be rigid or flexible. One or morecomponents or portions of the device can be formed from a radiopaquematerial to facilitate visualization under fluoroscopy and other imagingtechniques, or from a radiolucent material so as not to interfere withvisualization of other structures. Exemplary radiolucent materialsinclude carbon fiber and high-strength polymers.

Although specific embodiments are described above, it should beunderstood that numerous changes may be made within the spirit and scopeof the concepts described.

1-59. (canceled)
 60. A bone anchor assembly, comprising: a receivermember having proximal and distal ends that define a centralproximal-distal axis; an insert attached to the receiver member, theinsert and the receiver member defining a cavity; a collet disposed inthe cavity and retained within the cavity by the insert, the colletincluding a plurality of fingers; and a shank that extends through theinsert, the shank having a head portion retained within the fingers ofthe collet.
 61. The assembly of claim 60, wherein the insert includes aridge received within a groove formed in the receiver member to attachthe insert to the receiver member.
 62. The assembly of claim 60, whereinthe insert is radially collapsible and expandable to facilitateinsertion of the insert into the receiver member.
 63. The assembly ofclaim 60, wherein the insert is threaded into an open distal end of thereceiver member.
 64. The assembly of claim 60, wherein the collet isinsertable into the distal end of the receiver member without deformingthe collet.
 65. The assembly of claim 60, wherein the receiver membercomprises first and second opposed arms that define a rod-receivingrecess therebetween.
 66. The assembly of claim 60, wherein the fingersof the collet are configured to deform from a resting position as thehead portion of the shank is loaded into a distal end of the collet and,once the head portion is advanced into the collet, the fingers areconfigured to return towards their resting position to capture the headportion within the collet.
 67. The assembly of claim 60, wherein theshank is free to pivot relative to the collet when the head portion isreceived within the fingers of the collet before the collet is locked tothe receiver member.
 68. The assembly of claim 60, wherein proximaladvancement of the receiver member with respect to the collet wedges thecollet fingers between the head portion of the shank and the interior ofthe insert, thereby locking movement of the shank with respect to thereceiver member.
 69. The assembly of claim 60, wherein the colletcomprises a compression cap and a collet ring.
 70. The assembly of claim69, wherein the compression cap and the collet ring are independentlylongitudinally-translatable relative to the receiver member whendisposed within the cavity.
 71. The assembly of claim 69, wherein thecompression cap is slidably received within an opening formed in thecollet ring.
 72. The assembly of claim 69, wherein the collet ringincludes a proximal opening in which the compression cap is slidablyreceived and wherein the fingers of the collet extend distally from thecollet ring.
 73. The assembly of claim 69, wherein the compression capincludes one or more flats that interact with respective one or moreflats of the receiver member to limit rotation of the compression caprelative to the receiver member about the central proximal-distal axis.74. The assembly of claim 69, wherein the cavity includes an upperportion having a cylindrical inner sidewall that constrains acylindrical outer sidewall of the collet ring when the collet ring isreceived therein.
 75. The assembly of claim 69, wherein tightening aclosure element to the receiver member (i) urges a bearing surface ofthe compression cap against a proximal portion of the head of the shankand (ii) urges the collet fingers against a distal portion of the headof the shank.
 76. A method of assembling a bone anchor assembly,comprising: inserting a collet into a cavity formed in a receiver memberof the bone anchor assembly by passing the collet through a distalopening of the cavity without deforming the collet; after inserting thecollet into the cavity, attaching an insert to the receiver member ofthe bone anchor assembly to prevent the collet from moving distallythrough the distal opening of the cavity; and after attaching the insertto the receiver member, inserting a head portion of a bone anchorthrough a central opening of the insert and into the collet by:deforming the fingers of the collet radially-outward to allow the headportion of the bone anchor to pass through a distal opening defined bythe fingers; and collapsing the plurality of fingers radially-inwardonce the head portion is disposed within the collet to retain the headportion within the collet.
 77. The method of claim 76, furthercomprising translating the receiver member proximally relative to thecollet to wedge the fingers of the collet between the head portion ofthe bone anchor and an interior surface of the insert.
 78. The method ofclaim 76, wherein translating the receiver member proximally comprisestightening a set screw to the receiver member to urge a rod disposed inthe receiver member into contact with the collet to move the receivermember proximally.
 79. The method of claim 76, further comprisingdriving the bone anchor into bone prior to attaching the collet and thereceiver member to the bone anchor.
 80. The method of claim 76, whereinthe collet comprises a compression cap and a collet ring, the fingersextending distally from the collet ring.
 81. The method of claim 80,further comprising independently longitudinally translating thecompression cap and the collet ring within the cavity.
 82. The method ofclaim 80, further comprising sliding the compression cap axially withinan opening formed in the collet ring.
 83. The method of claim 80,wherein the compression cap includes one or more flats that interactwith respective one or more flats of the receiver member to limitrotation of the compression cap relative to the receiver member about acentral proximal-distal axis of the receiver member.
 84. The method ofclaim 80, further comprising tightening a closure element to thereceiver member to (i) urge a bearing surface of the compression capagainst a proximal portion of the head of the bone anchor and (ii) urgethe collet fingers against a distal portion of the head of the boneanchor.